FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIRTHING ROOM WARMER
K Number: K871594
·
Decision Jun 5, 1987
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
33
Review Days
42
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Basic Information
- Device Name
- BIRTHING ROOM WARMER
- K Number
- K871594
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Air-Shields, Inc.
- Date Received
- April 24, 1987
- Decision Date
- June 5, 1987
- 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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|---|---|---|---|
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| K971256 | DUO-LITE PHOTOTHERAPY SYSTEM | Sep 24, 1997 | Substantially Equivalent |
| K960980 | ISOLETTE INFANT INCUBATOR | Jul 30, 1996 | Substantially Equivalent |
| K924709 | SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE | Jan 17, 1996 | Substantially Equivalent |
| K940951 | RW RESUCITAIRE INFANT RADIANT WARMER | May 3, 1995 | Substantially Equivalent |
| K940975 | C450/C400 INFANT INCUBATORS | Jun 23, 1994 | Substantially Equivalent |
| K941106 | MODEL TI500 ISOLETTE INFANT INCUBATOR | Jun 10, 1994 | Substantially Equivalent |
| K924170 | ISOLETTE INCUBATOR HUMIDITY METER | Feb 5, 1993 | Substantially Equivalent |
| K922150 | EXAMINATION LAMP | Jul 21, 1992 | Substantially Equivalent |