510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K082280Substantially Equivalent

Suresigns Vs2 Vital Signs Monitor, Suresigns Vm1 Patient Monitor, Suresigns Vs3 Cital Signs Monitor

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

K082280 is the FDA 510(k) clearance record for SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR, a class II device, cleared for Philips Medical Systems North America Co. 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 K082280.

Clearance record

Decision date
Received
(58 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 North America Co. 22100 Bothell Everett Hwy., Bothell WA
510(k) summary
Summary PDF
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