510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961582Substantially Equivalent

External Pacemaker Analyzer, Model Pmt 100

North American Technical Services Corp., Sound Beach NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961582 is the FDA 510(k) clearance record for EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100, a class II device, cleared for North American Technical Services Corp. on under FDA product code DTC (Analyzer, Pacemaker Generator Function). FDA records list 9 510(k) clearances for North American Technical Services Corp., from to . As of , FDA records show no recalls naming K961582.

Clearance record

Decision date
Received
(198 days to decision)
Product code
DTC Analyzer, Pacemaker Generator Function
Regulation
21 CFR 870.3630
Device class
Class II
Review panel
Cardiovascular
Applicant
North American Technical Services Corp. 30 Northport Rd., Sound Beach NY
510(k) summary
Statement
Third party review
No

Clearances, product code DTC

Trailing 12 months

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

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