Re: [PSES] safety test equipment

2018-10-09 Thread John Allen
Brian Commiserations on yourself "no longer needed" (really?) - but I hope/am sure that you will soon find a more-realistic company with a rewarding position J. John E Allen W. London, UK PS: I can say, with relative certainty, that before retiring a few years ago, I had "been

[PSES] safety test equipment

2018-10-09 Thread Brian O'Connell
Employer is focusing on a smaller segment of the power industry. Myself and test equipment no longer needed are being eliminated. Following list of safety test equipment is free to good home. Your company provides shipping. And you must agree to incorporate the various Klingon rites of

Re: [PSES] Does incorporated barcode scanner result in a new laser product?

2018-10-09 Thread Schmidt, Mark
Hmmm it does exist, however their definition I suspect is somewhat inappropriate. I guess if you consider self-declaration a form of certification, then yes I would agree with you. Too bad OSHA and other globally recognized bodies do not accept products that I deem “CERTIFIED” an acceptable

Re: [PSES] Does incorporated barcode scanner result in a new laser product?

2018-10-09 Thread Schmidt, Mark
It's been a while since I had to deal with this stuff but ask the manufacturer for the CDRH Accession Number, then conduct a search for it to assure its validity. This typically means that all the proper steps and paperwork were filed with the CDRH by the original manufacturer. It does not mean

Re: [PSES] Does incorporated barcode scanner result in a new laser product?

2018-10-09 Thread Jim Hulbert
We've had no problem getting an NRTL to approve a UL-listed, FDA/CDRH compliant class 2 laser product in our end system. No additional testing was required. Jim Hulbert From: Nyffenegger, Dave [mailto:dave.nyffeneg...@bhemail.com] Sent: Tuesday, October 09, 2018 9:11 AM To:

Re: [PSES] Does incorporated barcode scanner result in a new laser product?

2018-10-09 Thread Lauren Crane
Just FYI regarding "certified". A Laser is a type of Electronic Product under 21CFR. All Electronic Products for which there is an applicable standard in 21CFR subpart J (such as lasers) must be certified. This is essentially an act of self-declaration. TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD

Re: [PSES] Does incorporated barcode scanner result in a new laser product?

2018-10-09 Thread Nyffenegger, Dave
It would seem if the argument holds that a new product is not being created when incorporating a laser then the supplier of the system is still subject to the CDRH requirements for Dealer and Distributor Records. There's an exception if the retail price is under $50. That's probably 1973