510(k) K841968

DESERET DISPOSABLE PRESSURE TRANSDUCER by Parke-Davis Co. — Product Code DRS

K841968 is an FDA 510(k) premarket notification submitted by Parke-Davis Co. for the device "DESERET DISPOSABLE PRESSURE TRANSDUCER". The FDA issued a decision of Substantially Equivalent on August 6, 1984. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Parke-Davis Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1984
Date Received
May 15, 1984
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