FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DRAGER INFANT RADIANT WARMERN RH600
K Number: K953489
·
Decision Feb 9, 1996
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
20
Review Days
199
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Basic Information
- Device Name
- DRAGER INFANT RADIANT WARMERN RH600
- K Number
- K953489
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Drager, Inc.
- Date Received
- July 25, 1995
- Decision Date
- February 9, 1996
- 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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