510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K831262Substantially Equivalent

Data IV Ambulatory Monitor

Cardio-Scan of Texas, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831262 is the FDA 510(k) clearance record for DATA IV AMBULATORY MONITOR, a class II device, cleared for Cardio-Scan of Texas on under FDA product code DSH (Recorder, Magnetic Tape, Medical). FDA records list one 510(k) clearance for Cardio-Scan of Texas. As of , FDA records show no recalls naming K831262.

Clearance record

Decision date
Received
(37 days to decision)
Product code
DSH Recorder, Magnetic Tape, Medical
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardio-Scan of Texas 803 N. Front St. Suite 3, Mchenry IL
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