The following data is part of a premarket notification filed by Midwest Reprocessing Center Llc with the FDA for Midwestern Reprocessing Center Reprocessed Pulse Oximeter Probe.
| Device ID | K101280 |
| 510k Number | K101280 |
| Device Name: | MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE |
| Classification | Oximeter, Reprocessed |
| Applicant | MIDWEST REPROCESSING CENTER LLC 434 INDUSTRIAL LANE Birmingham, AL 35211 |
| Contact | Jerome James |
| Correspondent | Jerome James MIDWEST REPROCESSING CENTER LLC 434 INDUSTRIAL LANE Birmingham, AL 35211 |
| Product Code | NLF |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-06 |
| Decision Date | 2010-10-07 |
| Summary: | summary |