FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
INFA WARMER I
K Number: K102227
·
Decision Jan 21, 2011
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
10
Review Days
165
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Basic Information
- Device Name
- INFA WARMER I
- K Number
- K102227
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Atom Medical Corporation
- Date Received
- August 9, 2010
- Decision Date
- January 21, 2011
- 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 Atom Medical Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K123937 | ATOM TRANSCAPSULE V-707 | May 23, 2013 | Substantially Equivalent |
| K120937 | SUNFLOWER WARNER | Jul 6, 2012 | Substantially Equivalent |
| K111547 | BILI-THERAPY PAD TYPE | Apr 12, 2012 | Substantially Equivalent |
| K103317 | RESUSCITATION UNIT 105 | Apr 20, 2011 | Substantially Equivalent |
| K102542 | RESUSCI FLOW; RESUSCI FLOW 104 | Apr 6, 2011 | Substantially Equivalent |
| K103828 | BILI-THERAPY SPOT TYPE | Mar 29, 2011 | Substantially Equivalent |
| K102226 | DUAL INCU I | Jan 4, 2011 | Substantially Equivalent |
| K102279 | INCU I | Dec 29, 2010 | Substantially Equivalent |
| K102710 | NEO-SERVO I | Dec 22, 2010 | Substantially Equivalent |