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 | K020974 |
| 510k Number | K020974 |
| Device Name: | BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER |
| Classification | Chamber, Hyperbaric |
| Applicant | ENVIRONMENTAL TECTONICS CORP. 125 JAMES WAY Southampton, PA 18966 -3877 |
| Contact | Michael W Allen |
| Correspondent | Michael W Allen ENVIRONMENTAL TECTONICS CORP. 125 JAMES WAY Southampton, PA 18966 -3877 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-26 |
| Decision Date | 2002-06-26 |
| Summary: | summary |