510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K090483Substantially Equivalent

Sursigns Vs2 Vital Signs Monitor, Suresigns Vs3 Vital Signs Monitor, Suresigns Vm Series Patient Monitors

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

K090483 is the FDA 510(k) clearance record for SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS, a class II device, cleared for Philips Medical Systems 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 5 recalls naming K090483.

Clearance record

Decision date
Received
(23 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Philips Medical Systems 3000 Minuteman Rd., Andover MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DPS

Trailing 12 months
6 clearances under product code DPS in the twelve months to October 2026, September 2026 the highest month at 2.
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 20262
October 20260