The following data is part of a premarket notification filed by Sorensen Research with the FDA for Transducer Dome Sd105.
Device ID | K833095 |
510k Number | K833095 |
Device Name: | TRANSDUCER DOME SD105 |
Classification | Transducer, Blood-pressure, Extravascular |
Applicant | SORENSEN RESEARCH 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 | 1983-09-12 |
Decision Date | 1983-11-03 |