The following data is part of a premarket notification filed by Neuro-diagnostic Assoc. with the FDA for Medi-dx 7000.
| Device ID | K964622 |
| 510k Number | K964622 |
| Device Name: | MEDI-DX 7000 |
| Classification | Device, Vibration Threshold Measurement |
| Applicant | NEURO-DIAGNOSTIC ASSOC. 445 DARTMOOR ST. Laguna Beach, CA 92651 |
| Contact | James Hedgecock |
| Correspondent | James Hedgecock NEURO-DIAGNOSTIC ASSOC. 445 DARTMOOR ST. Laguna Beach, CA 92651 |
| Product Code | LLN |
| CFR Regulation Number | 882.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-18 |
| Decision Date | 1997-12-01 |
| Summary: | summary |