510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880780Substantially Equivalent

Heartstart 2000 Defibrillator Tester, ECG

First Medical Devices Corp., Bellevue WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880780 is the FDA 510(k) clearance record for HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG, a class II device, cleared for First Medical Devices Corp. on under FDA product code DRL (Tester, Defibrillator). FDA records list 7 510(k) clearances for First Medical Devices Corp., from to . As of , FDA records show no recalls naming K880780.

Clearance record

Decision date
Received
(76 days to decision)
Product code
DRL Tester, Defibrillator
Regulation
21 CFR 870.5325
Device class
Class II
Review panel
Cardiovascular
Applicant
First Medical Devices Corp. 2445 140th Ave. NE Suite 150, Bellevue WA
Third party review
No

Clearances, product code DRL

Trailing 12 months

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

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