The following data is part of a premarket notification filed by Quartet Technology, Inc. with the FDA for Simplicity Series 5.
| Device ID | K881634 |
| 510k Number | K881634 |
| Device Name: | SIMPLICITY SERIES 5 |
| Classification | System, Environmental Control, Powered |
| Applicant | QUARTET TECHNOLOGY, INC. 52 DAVIS RD. TYNGSBORO, MA 01879 |
| Contact | STEVE MINER |
| Correspondent | STEVE MINER QUARTET TECHNOLOGY, INC. 52 DAVIS RD. TYNGSBORO, MA 01879 |
| Product Code | IQA |
| CFR Regulation Number | 890.3725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-14 |
| Decision Date | 1988-05-17 |