The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Pulse Oximeter Sensors.
| Device ID | K092368 |
| 510k Number | K092368 |
| Device Name: | REPROCESSED PULSE OXIMETER SENSORS |
| Classification | Oximeter, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Garrett Ahlborg |
| Correspondent | Garrett Ahlborg STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Product Code | NLF |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-05 |
| Decision Date | 2009-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888551042526 | K092368 | 000 |
| 20888551042373 | K092368 | 000 |
| 20888551042380 | K092368 | 000 |
| 20888551042397 | K092368 | 000 |
| 20888551042403 | K092368 | 000 |
| 20888551042410 | K092368 | 000 |
| 20888551042427 | K092368 | 000 |
| 20888551042472 | K092368 | 000 |
| 20888551042489 | K092368 | 000 |
| 20888551042496 | K092368 | 000 |
| 20888551042502 | K092368 | 000 |
| 20888551042519 | K092368 | 000 |
| 20888551042366 | K092368 | 000 |