510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961138Substantially Equivalent

Esort II + 400 Series Monitor

Medical Data Electronics, Arleta CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961138 is the FDA 510(k) clearance record for ESORT II + 400 SERIES MONITOR, a class II device, cleared for Medical Data Electronics on under FDA product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)). FDA records list 27 510(k) clearances for Medical Data Electronics, from to . As of , FDA records show no recalls naming K961138.

Clearance record

Decision date
Received
(264 days to decision)
Product code
DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Regulation
21 CFR 870.5550
Device class
Class II
Review panel
Cardiovascular
Applicant
Medical Data Electronics 12720 Wentworth St., Arleta CA
510(k) summary
Statement
Third party review
No

Clearances, product code DRO

Trailing 12 months

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

FDA records show no clearances under product code DRO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRO, 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