510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K912427Substantially Equivalent

Multichannel Recording System

Bionique, Beaverton OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912427 is the FDA 510(k) clearance record for MULTICHANNEL RECORDING SYSTEM, a class II device, cleared for Bionique on under FDA product code DSH (Recorder, Magnetic Tape, Medical). FDA records list one 510(k) clearance for Bionique. As of , FDA records show no recalls naming K912427.

Clearance record

Decision date
Received
(56 days to decision)
Product code
DSH Recorder, Magnetic Tape, Medical
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Bionique 14225 Southwest Wilson Dr., Beaverton OR
510(k) summary
Statement
Third party review
No

Clearances, product code DSH

Trailing 12 months
3 clearances under product code DSH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260