FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)
K Number: K092991
·
Decision Aug 13, 2010
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
68
Applicant Total
3
Review Days
319
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Basic Information
- Device Name
- O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)
- K Number
- K092991
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5470
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Environmental Tectonics Corp.
- Date Received
- September 28, 2009
- Decision Date
- August 13, 2010
- Product Code
- CBF
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CBF | Chamber, Hyperbaric | FDA class 2 | Anesthesiology |
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