510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050399Substantially Equivalent

MRI Compatible Patient Monitoring System, Model 3160

Invivo Research, Inc., Orlando FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050399 is the FDA 510(k) clearance record for MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160, a class II device, cleared for Invivo Research, Inc. on under FDA product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)). FDA records list 14 510(k) clearances for Invivo Research, Inc., from to . As of , FDA records show no recalls naming K050399.

Clearance record

Decision date
Received
(191 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
Invivo Research, Inc. 12601 Research Pkwy., Orlando FL
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