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510(k) K130951

SIM by Simavita Pty Limited — Product Code KPN

K130951 is an FDA 510(k) premarket notification submitted by Simavita Pty Limited for the device "SIM". The FDA issued a decision of Substantially Equivalent on August 22, 2013. The device falls under product code KPN (Alarm, Conditioned Response Enuresis), a Class II device regulated under 21 CFR 876.2040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2013
Date Received
April 5, 2013
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 for product code KPN

  • 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)
  • K942057 — FISHER-PRICE DRY NIGHT MONITOR (July 28, 1994)
  • K935915 — WET SENSE (May 13, 1994)
  • K934369 — DRI SLEEPER (November 24, 1993)

FDA data resources