FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PM PUMP COMPRESSOR
K Number: K930509
·
Decision Oct 28, 1994
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
73
Applicant Total
29
Review Days
634
Basic Information
- Device Name
- PM PUMP COMPRESSOR
- K Number
- K930509
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.6250
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- PRECISION MEDICAL, INC.
- Date Received
- February 1, 1993
- Decision Date
- October 28, 1994
- 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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| K051691 | MINIMATE COMPRESSOR | Dec 9, 2005 | Substantially Equivalent |
| K041122 | PRECISION LIQUID OXYGEN SYSTEM | Oct 4, 2004 | Substantially Equivalent |
| K032018 | EASY PULSE II OXYGEN CONSERVER | Aug 25, 2003 | Substantially Equivalent |