ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA
FDA 510(k) clearance K100523 · decided 2010-05-04
Clearance details
- K-number
- K100523
- Device name
- ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA
- Applicant
- Hygia Health Services, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-02-24
- Decision date
- 2010-05-04
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- NMD
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Birmingham, AL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE (K111007) | Midwest Reprocessing Center, LLC | 2011-06-08 |
Recalls involving this device
No recalls on record reference this clearance.