The following data is part of a premarket notification filed by Medotech A/s with the FDA for Grindcare Measure.
| Device ID | K113677 |
| 510k Number | K113677 |
| Device Name: | GRINDCARE MEASURE |
| Classification | Device, Muscle Monitoring |
| Applicant | MEDOTECH A/S 13417 QUIVAS ST Westminster, CO 80234 |
| Contact | Calley Herzog |
| Correspondent | Calley Herzog MEDOTECH A/S 13417 QUIVAS ST Westminster, CO 80234 |
| Product Code | KZM |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-14 |
| Decision Date | 2012-04-05 |
| Summary: | summary |