The following data is part of a premarket notification filed by Vermont Medical, Inc. with the FDA for Ver Med A10011 Pns Dual Element Electrode.
| Device ID | K921498 |
| 510k Number | K921498 |
| Device Name: | VER MED A10011 PNS DUAL ELEMENT ELECTRODE |
| Classification | Stimulator, Nerve, Ac-powered |
| Applicant | VERMONT MEDICAL, INC. INDUSTRIAL PARK Bellows Falls, VT 05101 |
| Contact | Pamela Sopczyk |
| Correspondent | Pamela Sopczyk VERMONT MEDICAL, INC. INDUSTRIAL PARK Bellows Falls, VT 05101 |
| Product Code | BXM |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-31 |
| Decision Date | 1993-06-09 |