The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Reprocessed Masimo Pulse Oximeter Sensors.
| Device ID | K081238 |
| 510k Number | K081238 |
| Device Name: | REPROCESSED MASIMO PULSE OXIMETER SENSORS |
| Classification | Oximeter, Reprocessed |
| Applicant | ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Katie Bray |
| Correspondent | Katie Bray ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Product Code | NLF |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-01 |
| Decision Date | 2008-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885825016635 | K081238 | 000 |
| 50885825016628 | K081238 | 000 |
| 50885825016604 | K081238 | 000 |
| 50885825016598 | K081238 | 000 |
| 50885825016383 | K081238 | 000 |
| 50885825015867 | K081238 | 000 |
| 50885825015850 | K081238 | 000 |
| 50885825015843 | K081238 | 000 |
| 50885825015836 | K081238 | 000 |