510(k) K100523
- Device
- ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA
- Applicant
- HYGIA HEALTH SERVICES, INC.
- 510(k) number
- K100523
- Product code
- NMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-05-04
- Date received
- 2010-02-24
- Regulation
- 870.2700
- Classification name
- Oximeter, Tissue Saturation, Reprocessed
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LAKE TRECHSEL
- Address
- 434 Industrial Ln. Birmingham AL US 35211 35211
FDA Registration Numbers#
- 1018470
Source Documents#
Other 510(k) Records For Product Code NMD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K111007 | MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE | Midwest Reprocessing Center, LLC | 2011-06-08 |
Legacy Summary#
summary
FDA Review#
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