The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Transducer, Pressure, Option, H-p, P23id.
Device ID | K780797 |
510k Number | K780797 |
Device Name: | TRANSDUCER, PRESSURE, OPTION, H-P, P23ID |
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 | 1978-05-15 |
Decision Date | 1978-06-13 |