HEART-ALERT— 510(k) K820444

Substantially Equivalent

Medical Equipment Devices, Inc.

FDA 510(k) clearance K820444 for HEART-ALERT, Substantially Equivalent on 1982-03-12. Applicant: Medical Equipment Devices, Inc.. Device class: 1.

Clearance details

Applicant: Medical Equipment Devices, Inc.
Product code: Code KHX
Device class: Class 1
Regulation: 21 CFR 890.1575
Advisory panel: Physical Medicine
Date received: 1982-02-18
Decision date: 1982-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHX

K951771 — COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPM1995-08-11
K946229 — BALANCE MANAGER1995-08-04
K942694 — STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-3021995-03-10
K930089 — SMS BALANCE PERFORMANCE MONITOR1993-06-08
K921340 — FORCE MEASURING PLATFORM1992-05-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.