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510(k) K834311

NIGHT TRAINER by Maddak, Inc. — Product Code KPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1984
Date Received
November 25, 1983
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 Maddak, Inc.

  • K841700 — WALK & ROLL (May 11, 1984)
  • K841695 — CRAWLER (May 10, 1984)
  • K841698 — HEAT PACK (May 10, 1984)
  • K841697 — HYDRO-THERO PAD (May 9, 1984)
  • K841693 — STANDING FRAME (May 9, 1984)
  • K841692 — PRONE STANDER (May 9, 1984)
  • K841691 — SPLIT SEAT POSITIONING CHAIR (May 9, 1984)
  • K833870 — KNEE WALKER (November 29, 1983)
  • K833177 — GLOSSECTOMY FEEDING SPOONS (October 31, 1983)
  • K833090 — SENSORY ROLLER MASSAGER (October 14, 1983)

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)
  • K943558 — PRO'TECT (May 24, 1995)
  • K943559 — REMOTE A'LERT (May 24, 1995)
  • K942057 — FISHER-PRICE DRY NIGHT MONITOR (July 28, 1994)
  • K935915 — WET SENSE (May 13, 1994)