The following data is part of a premarket notification filed by Noromed, Inc. with the FDA for Norodyn 2000 Electromyograph.
| Device ID | K922838 |
| 510k Number | K922838 |
| Device Name: | NORODYN 2000 ELECTROMYOGRAPH |
| Classification | Device, Biofeedback |
| Applicant | NOROMED, INC. 720 OLIVE WAY SUITE 800 Seattle, WA 98101 |
| Contact | Adib |
| Correspondent | Adib NOROMED, INC. 720 OLIVE WAY SUITE 800 Seattle, WA 98101 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-12 |
| Decision Date | 1993-09-22 |