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

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

21 CFR 870.2300 / Cardiovascular
FDA source (opens on fda.gov)

MWI is the FDA product code for Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), a class II device type, regulated under 21 CFR 870.2300. As of , FDA records hold 308 510(k) clearances under this code, the most recent dated , and 81 recalls.

Classification record

Product code
MWI
Device name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
308
Ingested recalls
85

Clearances, product code MWI

By decision year
308 clearances under product code MWI with a decision year between 1999 and 2026, 2013 the highest year at 20.
Show the numbers
510(k) clearances under FDA product code MWI by decision year
YearClearances
19991
200012
200113
200212
200312
200415
200510
200614
20079
20089
20096
201017
201111
201213
201320
201416
201519
201612
201713
201811
201914
20208
20219
20225
20238
202410
20254
20265

Applicants with the most clearances

Product code MWI
Applicants holding the most 510(k) clearances under product code MWI
ApplicantClearances
Larsen & Toubro Limited15
Masimo Corporation13
GE Medical Systems Information Technologies, Inc.12
Invivo Corporation12
Welch Allyn Inc12
Agilent Technologies, Inc.11
Philips North America LLC11
AirStrip Technologies, Inc.9
Guangdong Biolight Meditech Co., Ltd7
Infinium Medical, Inc7

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 160 companies shown, in name order