The following data is part of a premarket notification filed by Midwest Reprocessing Center Llc with the FDA for Midwest Reprocessing Center Reprocessed Lncs Sessors; Midwest Reprocessing Center Reprocessed Oximax Sensors; Midwest Re.
| Device ID | K111007 |
| 510k Number | K111007 |
| Device Name: | MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE |
| Classification | Oximeter, Tissue Saturation, Reprocessed |
| Applicant | MIDWEST REPROCESSING CENTER LLC 434 INDUSTRIAL LANE Birmingham, AL 35211 |
| Contact | Scott Senner |
| Correspondent | Scott Senner MIDWEST REPROCESSING CENTER LLC 434 INDUSTRIAL LANE Birmingham, AL 35211 |
| Product Code | NMD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-11 |
| Decision Date | 2011-06-08 |
| Summary: | summary |