MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE
FDA 510(k) clearance K111007 · decided 2011-06-08
Clearance details
- K-number
- K111007
- Device name
- MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE
- Applicant
- Midwest Reprocessing Center, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-04-11
- Decision date
- 2011-06-08
- Days to decision
- 58 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 |
|---|---|---|
| ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA (K100523) | Hygia Health Services, Inc. | 2010-05-04 |
Recalls involving this device
No recalls on record reference this clearance.