The following data is part of a premarket notification filed by Vermed, Inc. with the FDA for Tender-trode Prewired Pediatric Ecg Electrode.
| Device ID | K090180 |
| 510k Number | K090180 |
| Device Name: | TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | VERMED, INC. 9 LOVELL DR. Bellows Falls, VT 05101 |
| Contact | Marc Fillion |
| Correspondent | Marc Fillion VERMED, INC. 9 LOVELL DR. Bellows Falls, VT 05101 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-23 |
| Decision Date | 2009-06-17 |
| Summary: | summary |