Cleared Traditional

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

K961223 · Criticare Systems, Inc. · Cardiovascular device
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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 after a review of 256 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Criticare Systems, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 125d · This submission: 256d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -