510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840358Substantially Equivalent

Impedance/8200 Monitor-Model 8300

Aequitron Medical, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840358 is the FDA 510(k) clearance record for IMPEDANCE/8200 MONITOR-MODEL 8300, a class II device, cleared for Aequitron Medical, Inc. on under FDA product code KRC (Tester, Electrode, Surface, Electrocardiographic). FDA records list 24 510(k) clearances for Aequitron Medical, Inc., from to . As of , FDA records show no recalls naming K840358.

Clearance record

Decision date
Received
(278 days to decision)
Product code
KRC Tester, Electrode, Surface, Electrocardiographic
Regulation
21 CFR 870.2370
Device class
Class II
Review panel
Cardiovascular
Applicant
Aequitron Medical, Inc. 14130 23rd. Ave. North, Minneapolis MN
Third party review
No

Clearances, product code KRC

Trailing 12 months

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

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