The following data is part of a premarket notification filed by Vanguard Medical Concepts, Inc. with the FDA for Vanguard Reprocessed Pulse Oximeter Sensors.
| Device ID | K012344 |
| 510k Number | K012344 |
| Device Name: | VANGUARD REPROCESSED PULSE OXIMETER SENSORS |
| Classification | Oximeter, Reprocessed |
| Applicant | VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR. Lakeland, FL 33815 |
| Contact | Mike Sammon |
| Correspondent | Mike Sammon VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR. Lakeland, FL 33815 |
| Product Code | NLF |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-24 |
| Decision Date | 2002-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885825014631 | K012344 | 000 |
| 50885825014600 | K012344 | 000 |
| 50885825014594 | K012344 | 000 |
| 50885825014341 | K012344 | 000 |
| 50885825013627 | K012344 | 000 |