FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISOLETTE INFANT INCUBATOR, MODEL C2HS
K Number: K001242
·
Decision Jul 13, 2000
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
84
Applicant Total
5
Review Days
86
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Basic Information
- Device Name
- ISOLETTE INFANT INCUBATOR, MODEL C2HS
- K Number
- K001242
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hill-Rom Air-Shields
- Date Received
- April 18, 2000
- Decision Date
- July 13, 2000
- 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 Hill-Rom Air-Shields
| K Number | Device Name | ||
|---|---|---|---|
| K021622 | HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 | Apr 1, 2003 | Substantially Equivalent |
| K003335 | RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER | Nov 17, 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 |