FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDICAL AIR COMPRESSOR, MODEL # 8413419
K Number: K982789
·
Decision Oct 29, 1998
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
73
Applicant Total
20
Review Days
80
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Basic Information
- Device Name
- MEDICAL AIR COMPRESSOR, MODEL # 8413419
- K Number
- K982789
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.6250
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Drager, Inc.
- Date Received
- August 10, 1998
- Decision Date
- October 29, 1998
- 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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| K961687 | EVITA 4 | Dec 13, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K950853 | OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS | Nov 5, 1996 | Substantially Equivalent - Subject to Tracking Reg. |