The following data is part of a premarket notification filed by Hygia Health Services, Inc. with the FDA for Adult Cerebral-somatic Oximetry Sensor, Pediatric Cerebral-somatic Oximetry Sensor Model Hhs-safb-sm, Hhs-spfb-usa.
| Device ID | K100523 |
| 510k Number | K100523 |
| Device Name: | ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA |
| Classification | Oximeter, Tissue Saturation, Reprocessed |
| Applicant | HYGIA HEALTH SERVICES, INC. 434 INDUSTRIAL LN. Birmingham, AL 35211 |
| Contact | Lake Trechsel |
| Correspondent | Lake Trechsel HYGIA HEALTH SERVICES, INC. 434 INDUSTRIAL LN. Birmingham, AL 35211 |
| Product Code | NMD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-24 |
| Decision Date | 2010-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30817357022194 | K100523 | 000 |
| 30817357020541 | K100523 | 000 |