510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962115Substantially Equivalent

Cambridge Heart Hi-Res ECG Electrode

Cambridge Heart, Inc., Bedford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962115 is the FDA 510(k) clearance record for CAMBRIDGE HEART HI-RES ECG ELECTRODE, a class II device, cleared for Cambridge Heart, Inc. on under FDA product code DRX (Electrode, Electrocardiograph). FDA records list 17 510(k) clearances for Cambridge Heart, Inc., from to . As of , FDA records show no recalls naming K962115.

Clearance record

Decision date
Received
(90 days to decision)
Product code
DRX Electrode, Electrocardiograph
Regulation
21 CFR 870.2360
Device class
Class II
Review panel
Cardiovascular
Applicant
Cambridge Heart, Inc. One Oak Park Dr., Bedford MA
510(k) summary
Summary
Third party review
No

Clearances, product code DRX

Trailing 12 months

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

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