FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEO-SERVO I
K Number: K102710
·
Decision Dec 22, 2010
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
84
Applicant Total
10
Review Days
93
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Basic Information
- Device Name
- NEO-SERVO I
- K Number
- K102710
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Atom Medical Corporation
- Date Received
- September 20, 2010
- Decision Date
- December 22, 2010
- 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 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 |
| K102227 | INFA WARMER I | Jan 21, 2011 | Substantially Equivalent |
| K102226 | DUAL INCU I | Jan 4, 2011 | Substantially Equivalent |
| K102279 | INCU I | Dec 29, 2010 | Substantially Equivalent |