The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Gould Disposable Transducer & Accessories-dtx.
| Device ID | K851486 |
| 510k Number | K851486 |
| Device Name: | GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | GOULD, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Contact | Archer S Gordon |
| Correspondent | Archer S Gordon GOULD, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-15 |
| Decision Date | 1985-10-17 |