FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDICAL AIR COMPRESSOR
K Number: K113338
·
Decision Aug 10, 2012
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
73
Applicant Total
4
Review Days
270
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Basic Information
- Device Name
- MEDICAL AIR COMPRESSOR
- K Number
- K113338
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.6250
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oricare, Inc.
- Date Received
- November 14, 2011
- Decision Date
- August 10, 2012
- Product Code
- BTI
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTI | Compressor, Air, Portable | FDA class 2 | Anesthesiology |
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