510(k) K863702

PULSE CUFF RECORDER MODEL PCR100 by Imex Medical Systems, Inc. — Product Code JOM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1987
Date Received
September 23, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class
Class II
Regulation Number
870.2780
Review Panel
CV
Submission Type