Cleared Traditional

K961223 - MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS
(FDA 510(k) Clearance)

Dec 1996
Decision
256d
Days
Risk

K961223 is an FDA 510(k) clearance for the MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS..

Submitted by Criticare Systems, Inc. (Waukesha, US). The FDA issued a Cleared decision on December 10, 1996, 256 days after receiving the submission on March 29, 1996.

This device falls under the Cardiovascular FDA review panel.

Submission Details

510(k) Number K961223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1996
Decision Date December 10, 1996
Days to Decision 256 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code LOS
Device Class