510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K861505Substantially Equivalent

Hipec Analyzer - Ha 100 Hi-Pro Multi-ECG Analyzer

American Medical Equipment, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861505 is the FDA 510(k) clearance record for HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER, a class II device, cleared for American Medical Equipment, Inc. on under FDA product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function). FDA records list one 510(k) clearance for American Medical Equipment, Inc. As of , FDA records show no recalls naming K861505.

Clearance record

Decision date
Received
(352 days to decision)
Product code
DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Regulation
21 CFR 870.1435
Device class
Class II
Review panel
Cardiovascular
Applicant
American Medical Equipment, Inc. 71 Fifth Ave., New York NY
Third party review
No

Clearances, product code DXG

Trailing 12 months
1 clearance under product code DXG in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260