SIM— 510(k) K130951

Substantially Equivalent

Simavita Pty Limited

FDA 510(k) clearance K130951 for SIM, Substantially Equivalent on 2013-08-22. Applicant: Simavita Pty Limited. Device class: 2.

Clearance details

Applicant: Simavita Pty Limited
Product code: Code KPN
Device class: Class 2
Regulation: 21 CFR 876.2040
Advisory panel: Gastroenterology, Urology
Date received: 2013-04-05
Decision date: 2013-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPN

K971442 — HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-51998-01-08
K971855 — POTTY PAL AND FOREVER-DRY1997-08-18
K962770 — UROSURGE ACUTRAINER1996-08-01
K962416 — DRYTIME FOR BLADDER CONTROL SILENT1996-07-22
K955338 — DRYTIME FOR POTTY TRAINING1996-03-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.