510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K013427Substantially Equivalent

Modification To:philips M3000a/m3046a Compact Portable Patient Monitor, Models Philips M3000a/m3046a

Philips North America LLC, Andover MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K013427 is the FDA 510(k) clearance record for MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A, a class II device, cleared for Philips Medical Systems, Inc. on under FDA product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K013427.

Clearance record

Decision date
Received
(44 days to decision)
Product code
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Philips Medical Systems, Inc. 3000 Minuteman Rd., Andover MA
510(k) summary
Summary
Third party review
No

Clearances, product code MHX

Trailing 12 months
15 clearances under product code MHX in the twelve months to November 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MHX, trailing twelve months
MonthClearances
December 20251
January 20261
February 20261
March 20260
April 20263
May 20262
June 20261
July 20261
August 20263
September 20261
October 20261
November 20260