510(k) K910764

THE PERCEPTOR(TM) STAND ALONE TRANSDUCER by North American Instrument Corp. — Product Code DRS

K910764 is an FDA 510(k) premarket notification submitted by North American Instrument Corp. for the device "THE PERCEPTOR(TM) STAND ALONE TRANSDUCER". The FDA issued a decision of Substantially Equivalent on April 22, 1991. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. North American Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1991
Date Received
January 31, 1991
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