THE BIOSONICS CONTINENCE CONTROL SYSTEM CCS(TM)— 510(k) K864448

Name: FDA 510(k) clearance K864448
Creator: U.S. Food and Drug Administration
Published: 1987-02-06

Substantially Equivalent

Biosonics, Inc.

FDA 510(k) clearance K864448 for THE BIOSONICS CONTINENCE CONTROL SYSTEM CCS(TM), Substantially Equivalent on 1987-02-06. Applicant: Biosonics, Inc.. Device class: 2.

Clearance details

Applicant: Biosonics, Inc.
Product code: Code KPN
Device class: Class 2
Regulation: 21 CFR 876.2040
Advisory panel: Gastroenterology, Urology
Date received: 1986-11-12
Decision date: 1987-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPN

view all

K130951 — SIM2013-08-22
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

More clearances from Biosonics, Inc.

view all

K882555 — ANOTRON(R) INCONTINENCE CONTROL SYSTEM1988-08-30
K862683 — BIOSOICS SPHINCTER TRAINING SYSTEM1986-11-12

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