FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BABYTHERM 8004 BABYTHERM 8010
K Number: K971198
·
Decision Oct 3, 1997
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
20
Review Days
186
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Basic Information
- Device Name
- BABYTHERM 8004 BABYTHERM 8010
- K Number
- K971198
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Drager, Inc.
- Date Received
- March 31, 1997
- Decision Date
- October 3, 1997
- Product Code
- FMT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMT | Warmer, Infant Radiant | FDA class 2 | General Hospital |
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| K982789 | MEDICAL AIR COMPRESSOR, MODEL # 8413419 | Oct 29, 1998 | Substantially Equivalent |
| K980642 | EVITA 4 (8411900) | Sep 4, 1998 | Substantially Equivalent |
| K974176 | BABYLOG 8000 PLUS | Jun 17, 1998 | Substantially Equivalent |
| K970165 | EVITA 2 DURA | Aug 26, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K954204 | DRAGER INCUBATOR 8000 IC | Apr 25, 1997 | Substantially Equivalent |
| 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. |