The following data is part of a premarket notification filed by Elcam Medical A.c.a.l. with the FDA for Elcam Vital Signs Wireless System (vsws).
| Device ID | K120253 |
| 510k Number | K120253 |
| Device Name: | ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | ELCAM MEDICAL A.C.A.L. KIBBUTZ BAR-AM D.n. Merom Hagalil, IL 13860 |
| Contact | Aharon Cohen |
| Correspondent | Aharon Cohen ELCAM MEDICAL A.C.A.L. KIBBUTZ BAR-AM D.n. Merom Hagalil, IL 13860 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-27 |
| Decision Date | 2012-07-16 |
| Summary: | summary |