The following data is part of a premarket notification filed by Environmental Tectonics Corp. with the FDA for Bara-med, Acrylic Monoplace Hyperbaric Chamber.
| Device ID | K993010 |
| 510k Number | K993010 |
| Device Name: | BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER |
| Classification | Chamber, Hyperbaric |
| Applicant | ENVIRONMENTAL TECTONICS CORP. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein ENVIRONMENTAL TECTONICS CORP. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-07 |
| Decision Date | 2000-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852678007122 | K993010 | 000 |