The following data is part of a premarket notification filed by Hygia Health Services, Inc. with the FDA for Hygia Health Services Reprocessed Lncs Sensors, Models Hhs-1858, Hhs-1862, Hhs-1860 And Hhs-1861.
| Device ID | K080424 |
| 510k Number | K080424 |
| Device Name: | HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861 |
| Classification | Oximeter, Reprocessed |
| Applicant | HYGIA HEALTH SERVICES, INC. 434 INDUSTRIAL LN. Birmingham, AL 35211 |
| Contact | Jerome James |
| Correspondent | Jerome James HYGIA HEALTH SERVICES, INC. 434 INDUSTRIAL LN. Birmingham, AL 35211 |
| Product Code | NLF |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-15 |
| Decision Date | 2008-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30817357021418 | K080424 | 000 |
| 30817357020978 | K080424 | 000 |
| 30817357020725 | K080424 | 000 |
| 30817357020466 | K080424 | 000 |
| 30817357020336 | K080424 | 000 |
| 30817357020183 | K080424 | 000 |
| 30817357020091 | K080424 | 000 |
| 30817357020053 | K080424 | 000 |