FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇷 Argentina
INFANT WARMER
K Number: K931529
·
Decision Mar 11, 1994
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
6
Review Days
350
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Basic Information
- Device Name
- INFANT WARMER
- K Number
- K931529
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medix I.C.S.A.
- Date Received
- March 26, 1993
- Decision Date
- March 11, 1994
- 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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|---|---|---|---|
| K103735 | MEDILED MINI | Aug 15, 2011 | Substantially Equivalent |
| K083179 | MEDILED PHOTOTHERAPY LAMP | Feb 27, 2009 | Substantially Equivalent |
| K070291 | MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX | Sep 21, 2007 | Substantially Equivalent |
| K931965 | MEDIX PHOTOTHERAPY LAMP | Dec 9, 1993 | Substantially Equivalent |
| K920049 | MEDIX PC-305 NEONATAL INCUBATOR | May 21, 1993 | Substantially Equivalent |