510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K124000Substantially Equivalent

Medapps 2.0 - Remote Patient Monitoring System

Medapps Inc., dba Alere Connect, Scottsdale AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K124000 is the FDA 510(k) clearance record for MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM, a class II device, cleared for Medapps Inc., Dba Alere Connect on under FDA product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency). FDA records list 2 510(k) clearances for Medapps Inc., Dba Alere Connect, from to . As of , FDA records show no recalls naming K124000.

Clearance record

Decision date
Received
(216 days to decision)
Product code
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Regulation
21 CFR 870.2910
Device class
Class II
Review panel
Cardiovascular
Applicant
Medapps Inc., Dba Alere Connect 8767 E. Via De Ventura, Suite 300, Scottsdale AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRG

Trailing 12 months
2 clearances under product code DRG in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260