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 |