The following data is part of a premarket notification filed by Vermont Medical, Inc. with the FDA for Vermed A10021 Resting Ekg Tab Electrode.
| Device ID | K030073 |
| 510k Number | K030073 |
| Device Name: | VERMED A10021 RESTING EKG TAB ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | VERMONT MEDICAL, INC. INDUSTRIAL PARK Bellows Falls, VT 05101 |
| Contact | Marc Fillion |
| Correspondent | Marc Fillion VERMONT MEDICAL, INC. INDUSTRIAL PARK Bellows Falls, VT 05101 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-08 |
| Decision Date | 2003-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40857175006096 | K030073 | 000 |