Cleared Traditional

K834212 - N-CHANNEL (FDA 510(k) Clearance)

K834212 · Philips Medical Systems (Cleveland), Inc. · Cardiovascular device
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Nov 1984
Decision
344d
Days
-
Risk

K834212 is an FDA 510(k) clearance for the N-CHANNEL.

Submitted by Philips Medical Systems (Cleveland), Inc. (Walker, US). The FDA issued a Cleared decision on November 13, 1984 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Philips Medical Systems (Cleveland), Inc. devices

Submission Details

510(k) Number K834212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1983
Decision Date November 13, 1984
Days to Decision 344 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
219d slower than avg
Panel avg: 125d · This submission: 344d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -