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
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K920294Substantially Equivalent

Smi Model 210 Ambulatory ECG Monitoring System

Stuart Medical, Inc., North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920294 is the FDA 510(k) clearance record for SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM, cleared for Stuart Medical, Inc. on under FDA product code LOS. FDA records list 2 510(k) clearances for Stuart Medical, Inc., from to . As of , FDA records show no recalls naming K920294.

Clearance record

Decision date
Received
(167 days to decision)
Product code
LOS
Review panel
Unknown
Applicant
Stuart Medical, Inc. 45 W. St., North Attleboro MA
510(k) summary
Summary
Third party review
No

Clearances, product code LOS

Trailing 12 months

FDA records hold no clearances under product code LOS in the trailing twelve months.

FDA records show no clearances under product code LOS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LOS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260