HEART MONITOR BRACELET ALARM— 510(k) K822316

Substantially Equivalent

Hmba

FDA 510(k) clearance K822316 for HEART MONITOR BRACELET ALARM, Substantially Equivalent on 1982-09-21. Applicant: Hmba. Device class: 1.

Clearance details

Applicant: Hmba
Product code: Code DRI
Device class: Class 1
Regulation: 21 CFR 870.2620
Advisory panel: Cardiovascular
Date received: 1982-08-03
Decision date: 1982-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code DRI

K902492 — CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S1990-07-06
K902493 — CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR1990-07-06
K802326 — PRESSURE MONITORING LINES1980-10-10

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