The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Physiological Pressure Transducer #900.
Device ID | K820342 |
510k Number | K820342 |
Device Name: | PHYSIOLOGICAL PRESSURE TRANSDUCER #900 |
Classification | Transducer, Blood-pressure, Extravascular |
Applicant | BENTLEY LABORATORIES, 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 | 1982-02-08 |
Decision Date | 1982-03-04 |