510(k) K833094

TRANSDUCER DOME SD104 by Sorensen Research — Product Code DRS

K833094 is an FDA 510(k) premarket notification submitted by Sorensen Research for the device "TRANSDUCER DOME SD104". The FDA issued a decision of Substantially Equivalent on November 3, 1983. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Sorensen Research has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1983
Date Received
September 12, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Blood-Pressure, Extravascular
Device Class
Class II
Regulation Number
870.2850
Review Panel
CV
Submission Type