SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM
FDA 510(k) clearance K132402 · decided 2014-02-21
Clearance details
- K-number
- K132402
- Device name
- SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM
- Applicant
- Nonin Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-08-01
- Decision date
- 2014-02-21
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 80 recall (Z-0901-2015) | Nonin Medical, Inc | 2014-12-31 |