The following data is part of a premarket notification filed by Unimed Medical Supplies Inc. with the FDA for Reusable Ohmeda (u410-02), Datex (u410-09) Compatable Adult Finger Clip Sensor, Phillips Adult Soft Tip Sensor(u403s-91).
| Device ID | K082546 |
| 510k Number | K082546 |
| Device Name: | REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91) |
| Classification | Oximeter |
| Applicant | UNIMED MEDICAL SUPPLIES INC. W322S8863 MCCARTHY DR. Mukwonago, WI 53149 |
| Contact | Don Melnikoff |
| Correspondent | Don Melnikoff UNIMED MEDICAL SUPPLIES INC. W322S8863 MCCARTHY DR. Mukwonago, WI 53149 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-03 |
| Decision Date | 2008-12-02 |
| Summary: | summary |