510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971670Substantially Equivalent

3 Channel Digital Ambulatory ECG Recorder

Galix Biomedical Instrumentation, Inc., Miami Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971670 is the FDA 510(k) clearance record for 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER, a class II device, cleared for Galix Biomedical Instrumentation, Inc. on under FDA product code DSH (Recorder, Magnetic Tape, Medical). FDA records list 6 510(k) clearances for Galix Biomedical Instrumentation, Inc., from to . As of , FDA records show no recalls naming K971670.

Clearance record

Decision date
Received
(268 days to decision)
Product code
DSH Recorder, Magnetic Tape, Medical
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Galix Biomedical Instrumentation, Inc. 2555 Collins Ave., C-5, Miami Beach FL
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