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510(k) K962770

UROSURGE ACUTRAINER by Princeton Regulatory Assoc. — Product Code KPN

K962770 is an FDA 510(k) premarket notification submitted by Princeton Regulatory Assoc. for the device "UROSURGE ACUTRAINER". The FDA issued a decision of Substantially Equivalent on August 1, 1996. The device falls under product code KPN (Alarm, Conditioned Response Enuresis), a Class II device regulated under 21 CFR 876.2040. Princeton Regulatory Assoc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1996
Date Received
July 16, 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 Princeton Regulatory Assoc.

  • K965136 — UROSURGE UROTHERM FLUID WARMING SYSTEM (October 16, 1998)
  • K972158 — GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES (February 20, 1998)
  • K973504 — UROSURGE UROSTENT (January 30, 1998)

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)
  • 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