The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Electrocardiograph Lead Switching Adaptor.
| Device ID | K861981 |
| 510k Number | K861981 |
| Device Name: | ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR |
| Classification | Adaptor, Lead Switching, Electrocardiograph |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Craig Citron |
| Correspondent | Craig Citron VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Product Code | DRW |
| CFR Regulation Number | 870.2350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-22 |
| Decision Date | 1986-08-25 |