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510(k) K962416

DRYTIME FOR BLADDER CONTROL SILENT by Bio-Systems Research — Product Code KPN

K962416 is an FDA 510(k) premarket notification submitted by Bio-Systems Research for the device "DRYTIME FOR BLADDER CONTROL SILENT". The FDA issued a decision of Substantially Equivalent on July 22, 1996. The device falls under product code KPN (Alarm, Conditioned Response Enuresis), a Class II device regulated under 21 CFR 876.2040. Bio-Systems Research has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1996
Date Received
April 30, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alarm, Conditioned Response Enuresis
Device Class
Class II
Regulation Number
876.2040
Review Panel
GU
Submission Type

Other clearances by Bio-Systems Research

  • K933745 — PERMAGEN UNIVERSAL BONDING RESIN (January 26, 1994)

Other clearances for product code KPN

  • K130951 — SIM (August 22, 2013)
  • K971442 — HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,M (January 8, 1998)
  • K971855 — POTTY PAL AND FOREVER-DRY (August 18, 1997)
  • K962770 — UROSURGE ACUTRAINER (August 1, 1996)
  • K955338 — DRYTIME FOR POTTY TRAINING (March 12, 1996)
  • K943559 — REMOTE A'LERT (May 24, 1995)
  • K943558 — PRO'TECT (May 24, 1995)
  • K942057 — FISHER-PRICE DRY NIGHT MONITOR (July 28, 1994)
  • K935915 — WET SENSE (May 13, 1994)
  • K934369 — DRI SLEEPER (November 24, 1993)

FDA data resources