510(k) K831506

DISP. TRANSDUCER W/MONITORING KIT TRANS by Sorensen Research — Product Code DRS

K831506 is an FDA 510(k) premarket notification submitted by Sorensen Research for the device "DISP. TRANSDUCER W/MONITORING KIT TRANS". The FDA issued a decision of Substantially Equivalent on August 12, 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
August 12, 1983
Date Received
May 11, 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