Cleared Traditional

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

K834212 · Philips Medical Systems (Cleveland), Inc. · Cardiovascular device

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, 344 days after receiving the submission on December 5, 1983.

This device falls under the Cardiovascular FDA review panel.

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	—

Device Classification

Product Code	LOS
Device Class	—