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510(k) K942057

FISHER-PRICE DRY NIGHT MONITOR by Fisher Price — Product Code KPN

K942057 is an FDA 510(k) premarket notification submitted by Fisher Price for the device "FISHER-PRICE DRY NIGHT MONITOR". The FDA issued a decision of Substantially Equivalent on July 28, 1994. The device falls under product code KPN (Alarm, Conditioned Response Enuresis), a Class II device regulated under 21 CFR 876.2040. Fisher Price has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1994
Date Received
April 28, 1994
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 Fisher Price

  • K864399 — FISHER PRICE SUNJAMMERS (November 21, 1986)

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)
  • K962416 — DRYTIME FOR BLADDER CONTROL SILENT (July 22, 1996)
  • K955338 — DRYTIME FOR POTTY TRAINING (March 12, 1996)
  • K943559 — REMOTE A'LERT (May 24, 1995)
  • K943558 — PRO'TECT (May 24, 1995)
  • K935915 — WET SENSE (May 13, 1994)
  • K934369 — DRI SLEEPER (November 24, 1993)

FDA data resources