510(k) K961223

MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS by Criticare Systems, Inc. — Product Code LOS

K961223 is an FDA 510(k) premarket notification submitted by Criticare Systems, Inc. for the device "MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS". The FDA issued a decision of Substantially Equivalent on December 10, 1996. Criticare Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1996
Date Received
March 29, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No