DRY TIME— 510(k) K911279

Substantially Equivalent

Health Sense Intl., Inc.

FDA 510(k) clearance K911279 for DRY TIME, Substantially Equivalent on 1991-09-04. 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: 1991-03-25
Decision date: 1991-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coos Bay, OR, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPN

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K971855 — POTTY PAL AND FOREVER-DRY1997-08-18
K962770 — UROSURGE ACUTRAINER1996-08-01
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
K943559 — REMOTE A'LERT1995-05-24

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