The following data is part of a premarket notification filed by Somnitec, Inc. with the FDA for Ecg Female-to-pin Snap Electrode W/leads And Ext..
| Device ID | K911990 |
| 510k Number | K911990 |
| Device Name: | ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT. |
| Classification | Electrode, Electrocardiograph |
| Applicant | SOMNITEC, INC. 7732 BURNET AVE. Van Nuys, CA 91405 |
| Contact | Mark S London |
| Correspondent | Mark S London SOMNITEC, INC. 7732 BURNET AVE. Van Nuys, CA 91405 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-06 |
| Decision Date | 1991-06-21 |