The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Models Ta 1017 & 1017t Gritiflo Dispos.
Device ID | K811538 |
510k Number | K811538 |
Device Name: | MODELS TA 1017 & 1017T GRITIFLO DISPOS |
Classification | Transducer, Blood-pressure, Extravascular |
Applicant | GOULD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Contact | None None |
Correspondent | None None GOULD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DRS |
CFR Regulation Number | 870.2850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-06-01 |
Decision Date | 1981-06-12 |