510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020708Substantially Equivalent

Philips Pagewriter Touch Cardiograph, Model M5000a Series

Philips North America LLC, Andover MA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020708 is the FDA 510(k) clearance record for PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES, a class II device, cleared for Philips Medical Systems, Inc. on under FDA product code DPS (Electrocardiograph). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show 2 recalls naming K020708.

Clearance record

Decision date
Received
(51 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Philips Medical Systems, Inc. 3000 Minuteman Rd., Andover MA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DPS

Trailing 12 months
5 clearances under product code DPS in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DPS, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260