FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DRAGER INCUBATOR 8000 IC
K Number: K954204
·
Decision Apr 25, 1997
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
84
Applicant Total
20
Review Days
597
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Basic Information
- Device Name
- DRAGER INCUBATOR 8000 IC
- K Number
- K954204
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Drager, Inc.
- Date Received
- September 6, 1995
- Decision Date
- April 25, 1997
- Product Code
- FMZ
- 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 |
|---|---|---|---|
| FMZ | Incubator, Neonatal | FDA class 2 | General Hospital |
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Other Clearances by Drager, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992608 | ATC OPTION FOR EVITA 2 DURA AND EVITA 4 | Aug 24, 1999 | Substantially Equivalent |
| K984577 | DRAGER OXYLOG 2000 | Jan 22, 1999 | Substantially Equivalent |
| K983219 | NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900 | Dec 7, 1998 | Substantially Equivalent |
| 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 |
| K971198 | BABYTHERM 8004 BABYTHERM 8010 | Oct 3, 1997 | Substantially Equivalent |
| K970165 | EVITA 2 DURA | Aug 26, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| 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. |