REMOTE A'LERT— 510(k) K943559

Substantially Equivalent

Health Sense Intl., Inc.

FDA 510(k) clearance K943559 for REMOTE A'LERT, Substantially Equivalent on 1995-05-24. Applicant: Health Sense Intl., Inc.. Device class: 2.

Clearance details

Applicant: Health Sense Intl., Inc.
Product code: Code KPN
Device class: Class 2
Regulation: 21 CFR 876.2040
Advisory panel: Gastroenterology, Urology
Date received: 1994-07-22
Decision date: 1995-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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K962416 — DRYTIME FOR BLADDER CONTROL SILENT1996-07-22

More clearances from Health Sense Intl., Inc.

K955338 — DRYTIME FOR POTTY TRAINING1996-03-12
K943558 — PRO'TECT1995-05-24
K911279 — DRY TIME1991-09-04

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