DRY TIME

Alarm, Conditioned Response Enuresis

HEALTH SENSE INTL., INC.

The following data is part of a premarket notification filed by Health Sense Intl., Inc. with the FDA for Dry Time.

Pre-market Notification Details

• Device ID: K911279
• 510k Number: K911279
• Device Name: DRY TIME
• Classification: Alarm, Conditioned Response Enuresis
• Applicant: HEALTH SENSE INTL., INC. 201 SOUTH BROADWAY Coos Bay, OR 97420
• Contact: Larry F Fisher
• Correspondent: Larry F Fisher; HEALTH SENSE INTL., INC. 201 SOUTH BROADWAY Coos Bay, OR 97420
• Product Code: KPN
• CFR Regulation Number: 876.2040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-03-25
• Decision Date: 1991-09-04