FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
C450/C400 INFANT INCUBATORS
K Number: K940975
·
Decision Jun 23, 1994
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
84
Applicant Total
33
Review Days
112
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Basic Information
- Device Name
- C450/C400 INFANT INCUBATORS
- K Number
- K940975
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Air-Shields, Inc.
- Date Received
- March 3, 1994
- Decision Date
- June 23, 1994
- 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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|---|---|---|---|
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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 |
| 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 |
| K914864 | MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR | Mar 13, 1992 | Substantially Equivalent |