The following data is part of a premarket notification filed by Oktx Llc with the FDA for Physical Monitoring Registration Unit-s (pmru-s).
| Device ID | K123902 |
| 510k Number | K123902 |
| Device Name: | PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) |
| Classification | Electromyograph, Diagnostic |
| Applicant | OKTX LLC 7225 S 85TH E AVE. SUITE 300 Tulsa, OK 74137 |
| Contact | Mary Rose C Reaston |
| Correspondent | Mary Rose C Reaston OKTX LLC 7225 S 85TH E AVE. SUITE 300 Tulsa, OK 74137 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-18 |
| Decision Date | 2013-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B25972000 | K123902 | 000 |