The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Model:ta-rose Resonant Overshoot Eliminator.
| Device ID | K855145 |
| 510k Number | K855145 |
| Device Name: | MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | GOULD, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Contact | Gordon Ph.d. |
| Correspondent | Gordon Ph.d. 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 | 1985-12-24 |
| Decision Date | 1986-02-26 |