FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER
K Number: K003335
·
Decision Nov 17, 2000
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
5
Review Days
23
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Basic Information
- Device Name
- RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER
- K Number
- K003335
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hill-Rom Air-Shields
- Date Received
- October 25, 2000
- Decision Date
- November 17, 2000
- 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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Other Clearances by Hill-Rom Air-Shields
| K Number | Device Name | ||
|---|---|---|---|
| K021622 | HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 | Apr 1, 2003 | Substantially Equivalent |
| K001242 | ISOLETTE INFANT INCUBATOR, MODEL C2HS | Jul 13, 2000 | Substantially Equivalent |
| K001019 | TI500 GLOBE-TROTTER TRANSPORT SYSTEM | Apr 27, 2000 | Substantially Equivalent |
| K993051 | VERSALET 7700 CARE CENTER, MODEL # 7700 | Feb 3, 2000 | Substantially Equivalent |