The following data is part of a premarket notification filed by Hygia Health Services, Inc. with the FDA for Hygia Health Services Reprocessed Nellcot D-25 Oxisensor Ii.
| Device ID | K012715 |
| 510k Number | K012715 |
| Device Name: | HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II |
| Classification | Oximeter, Reprocessed |
| Applicant | HYGIA HEALTH SERVICES, INC. 2800 MILAN CT., SUITE 259 Birmingham, AL 35211 |
| Contact | Tracy Comas |
| Correspondent | Tracy Comas HYGIA HEALTH SERVICES, INC. 2800 MILAN CT., SUITE 259 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 | 2001-08-14 |
| Decision Date | 2003-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30817357020817 | K012715 | 000 |
| 30817357020619 | K012715 | 000 |