The following data is part of a premarket notification filed by Environmental Tectonics Corp. with the FDA for O.s.c.a.r. (operating System For Control And Record Keeping).
| Device ID | K092991 |
| 510k Number | K092991 |
| Device Name: | O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) |
| Classification | Chamber, Hyperbaric |
| Applicant | ENVIRONMENTAL TECTONICS CORP. 125 JAMES WAY Southampton, PA 18966 |
| Contact | Gene Davis |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-09-28 |
| Decision Date | 2010-08-13 |