510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812878Substantially Equivalent

The New 1600 Electrode

Andover Medical, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812878 is the FDA 510(k) clearance record for THE NEW 1600 ELECTRODE, a class II device, cleared for Andover Medical, Inc. on under FDA product code DRX (Electrode, Electrocardiograph). FDA records list 21 510(k) clearances for Andover Medical, Inc., from to . As of , FDA records show no recalls naming K812878.

Clearance record

Decision date
Received
(19 days to decision)
Product code
DRX Electrode, Electrocardiograph
Regulation
21 CFR 870.2360
Device class
Class II
Review panel
Cardiovascular
Applicant
Andover Medical, Inc. 4221 Richmond Rd., NW, Walker MI
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