510(k) K801894

RESPONDER II by Clinical Microsystems Intl. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1980
Date Received
August 8, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Breathing Frequency
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type