The following data is part of a premarket notification filed by Reimers Systems, Inc. with the FDA for T Class Hyperbaric Facilities.
| Device ID | K954387 |
| 510k Number | K954387 |
| Device Name: | T CLASS HYPERBARIC FACILITIES |
| Classification | Chamber, Hyperbaric |
| Applicant | REIMERS SYSTEMS, INC. 7668 FULLERTON RD. Springfield, VA 22153 -2818 |
| Contact | Stephen D Reimers |
| Correspondent | Stephen D Reimers REIMERS SYSTEMS, INC. 7668 FULLERTON RD. Springfield, VA 22153 -2818 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-19 |
| Decision Date | 1995-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850011262009 | K954387 | 000 |