510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020456Substantially Equivalent

Easi 12 Lead Algorithm

Philips North America LLC, Oxnard CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020456 is the FDA 510(k) clearance record for EASI 12 LEAD ALGORITHM, a class II device, cleared for Philips Medical Systems on under FDA product code DRW (Adaptor, Lead Switching, Electrocardiograph). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K020456.

Clearance record

Decision date
Received
(148 days to decision)
Product code
DRW Adaptor, Lead Switching, Electrocardiograph
Regulation
21 CFR 870.2350
Device class
Class II
Review panel
Cardiovascular
Applicant
Philips Medical Systems 1201b N. Rice Ave., Oxnard CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRW

Trailing 12 months

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

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