The following data is part of a premarket notification filed by Sorensen Research with the FDA for Disp. Transducer W/monitoring Kit Trans.
Device ID | K831506 |
510k Number | K831506 |
Device Name: | DISP. TRANSDUCER W/MONITORING KIT TRANS |
Classification | Transducer, Blood-pressure, Extravascular |
Applicant | SORENSEN RESEARCH 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DRS |
CFR Regulation Number | 870.2850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-11 |
Decision Date | 1983-08-12 |