The following data is part of a premarket notification filed by Flotec, Inc. with the FDA for Flotec Oxysavrr (s).
| Device ID | K970371 |
| 510k Number | K970371 |
| Device Name: | FLOTEC OXYSAVRR (S) |
| Classification | Conserver, Oxygen |
| Applicant | FLOTEC, INC. 8132 WOODLAND DR. Indianapolis, IN 46278 |
| Contact | Gilbert Davidson |
| Correspondent | Gilbert Davidson FLOTEC, INC. 8132 WOODLAND DR. Indianapolis, IN 46278 |
| Product Code | NFB |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-31 |
| Decision Date | 1997-07-10 |