The following data is part of a premarket notification filed by Transamerica Delaval, Inc. with the FDA for Dome, Disposable, Sterile.
| Device ID | K851989 |
| 510k Number | K851989 |
| Device Name: | DOME, DISPOSABLE, STERILE |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | TRANSAMERICA DELAVAL, INC. 325 HALSTEAD ST. P.O. BIN 7087 Pasadena, CA 91109 |
| Contact | Richard G Ekstrom |
| Correspondent | Richard G Ekstrom TRANSAMERICA DELAVAL, INC. 325 HALSTEAD ST. P.O. BIN 7087 Pasadena, CA 91109 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-07 |
| Decision Date | 1985-08-19 |