510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K113183Substantially Equivalent

Pms8210a (Iris) Multi-Parameter Patient Monitor, Model Code 500

Shanghai 3f Electronics Co, Ltd., Echo OR / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113183 is the FDA 510(k) clearance record for PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500, a class II device, cleared for Shanghai 3f Electronics Co, Ltd. on under FDA product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)). FDA records list 2 510(k) clearances for Shanghai 3f Electronics Co, Ltd., from to . As of , FDA records show no recalls naming K113183.

Clearance record

Decision date
Received
(104 days to decision)
Product code
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
Shanghai 3f Electronics Co, Ltd. 77325 Joyce Way, Echo OR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MWI

Trailing 12 months
5 clearances under product code MWI in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MWI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20262
September 20260
October 20260