510(k) K092991
K092991 is an FDA 510(k) premarket notification submitted by Environmental Tectonics Corp. for the device "O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)". The FDA issued a decision of Substantially Equivalent on August 13, 2010. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470. Environmental Tectonics Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 2010
- Date Received
- September 28, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Chamber, Hyperbaric
- Device Class
- Class II
- Regulation Number
- 868.5470
- Review Panel
- AN
- Submission Type