NEO-SERVO I
FDA 510(k) clearance K102710 · decided 2010-12-22
Clearance details
- K-number
- K102710
- Device name
- NEO-SERVO I
- Applicant
- Atom Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2010-09-20
- Decision date
- 2010-12-22
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- FMZ
- Device class
- 2
- Regulation number
- 880.5400
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bonita Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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| Babyleo TN500 (K182859) | Dragerwerk AG & CO Kgaa | 2019-02-22 |
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| Giraffe OmniBed Carestation CS1 (K152814) | Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company | 2016-03-17 |
| Giraffe Incubator Carestation CS1 (K152809) | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2015-12-31 |
Recalls involving this device
No recalls on record reference this clearance.