510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910109Substantially Equivalent

Cardioswiss Cm-8

Care Systems, Inc., Huntsville AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910109 is the FDA 510(k) clearance record for CARDIOSWISS CM-8, a class II device, cleared for Care Systems, Inc. on under FDA product code DSI (Detector And Alarm, Arrhythmia). FDA records list 3 510(k) clearances for Care Systems, Inc., from to . As of , FDA records show no recalls naming K910109.

Clearance record

Decision date
Received
(256 days to decision)
Product code
DSI Detector And Alarm, Arrhythmia
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Care Systems, Inc. 8300 Whitesburg Dr., Huntsville AL
Third party review
No

Clearances, product code DSI

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