The following data is part of a premarket notification filed by Myo-tronics, Inc. with the FDA for K6-i Diagnostic System.
| Device ID | K922456 |
| 510k Number | K922456 |
| Device Name: | K6-I DIAGNOSTIC SYSTEM |
| Classification | Device, Muscle Monitoring |
| Applicant | MYO-TRONICS, INC. 720 OLIVE WAY SUITE 800 Seattle, WA 98101 |
| Contact | Adib |
| Correspondent | Adib MYO-TRONICS, INC. 720 OLIVE WAY SUITE 800 Seattle, WA 98101 |
| Product Code | KZM |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-26 |
| Decision Date | 1994-06-09 |