510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K993643Substantially Equivalent

Nexsystem Ambulatory Patient Monitor Model Nex 100

Nexan Telemed, Ltd., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993643 is the FDA 510(k) clearance record for NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100, a class II device, cleared for Nexan Telemed , Ltd. on under FDA product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)). FDA records list one 510(k) clearance for Nexan Telemed , Ltd. As of , FDA records show no recalls naming K993643.

Clearance record

Decision date
Received
(61 days to decision)
Product code
MWJ Electrocardiograph, Ambulatory (Without Analysis)
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Nexan Telemed , Ltd. 15825 Shady Grove Rd., Rockville MD
510(k) summary
Summary
Third party review
No

Clearances, product code MWJ

Trailing 12 months
5 clearances under product code MWJ in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20261
September 20262
October 20260