The following data is part of a premarket notification filed by Elcam Medical A.c.a.l with the FDA for Elcam Disposable Integrated Pressure Transducer (dipt).
| Device ID | K120624 |
| 510k Number | K120624 |
| Device Name: | ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | ELCAM MEDICAL A.C.A.L M.P. MEROM HA'GALIL Kibbutz Baram, IL 13860 |
| Contact | Aharon Cohen |
| Correspondent | Aharon Cohen ELEAM MEDICAL A.C.A.L M.P. MEROM HA'GALIL Kibbutz Baram, IL 13860 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-01 |
| Decision Date | 2012-06-08 |
| Summary: | summary |