The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Pulse Oximeter Sensors.
| Device ID | K012677 |
| 510k Number | K012677 |
| Device Name: | REPROCESSED PULSE OXIMETER SENSORS |
| Classification | Oximeter, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Patrick Fleischhacker |
| Correspondent | Patrick Fleischhacker 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 | 2001-08-14 |
| Decision Date | 2003-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888551042229 | K012677 | 000 |
| 20888551042175 | K012677 | 000 |
| 20888551042168 | K012677 | 000 |