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 | K042316 |
| 510k Number | K042316 |
| Device Name: | VANGUARD REPROCESSED PULSE OXIMETER SENSORS |
| Classification | Oximeter, Reprocessed |
| Applicant | VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR. Lakeland, FL 33815 |
| Contact | Heather Crawford |
| Correspondent | Heather Crawford 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 | 2004-08-26 |
| Decision Date | 2005-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885825014624 | K042316 | 000 |
| 50885825014617 | K042316 | 000 |
| 50885825014358 | K042316 | 000 |
| 50885825014334 | K042316 | 000 |
| 50885825014327 | K042316 | 000 |