The following data is part of a premarket notification filed by American Bentley with the FDA for Trantecsilicone Quartz Disp. Transd.
Device ID | K833792 |
510k Number | K833792 |
Device Name: | TRANTECSILICONE QUARTZ DISP. TRANSD |
Classification | Transducer, Blood-pressure, Extravascular |
Applicant | AMERICAN BENTLEY 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 | 1983-10-31 |
Decision Date | 1984-02-10 |