510(k) K852547

CORTRONIC APM 770 NONINVASIVE & ARTERIAL PRESS MON by Cortronic Corp. — Product Code DQO

K852547 is an FDA 510(k) premarket notification submitted by Cortronic Corp. for the device "CORTRONIC APM 770 NONINVASIVE & ARTERIAL PRESS MON". The FDA issued a decision of Substantially Equivalent on November 10, 1986. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Cortronic Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1986
Date Received
June 14, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type