510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K983928Substantially Equivalent

Kodak Home Health Monitoring System

Eastman Kodak Company, Rochester NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983928 is the FDA 510(k) clearance record for KODAK HOME HEALTH MONITORING SYSTEM, a class II device, cleared for Eastman Kodak Company on under FDA product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)). FDA records list 291 510(k) clearances for Eastman Kodak Company, from to . As of , FDA records show no recalls naming K983928.

Clearance record

Decision date
Received
(463 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
Eastman Kodak Company 901 Elmgrove Rd., Rochester NY
510(k) summary
Statement
Third party review
No

Clearances, product code MWI

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