NYTONE ENURETIC ALARM BEDWETTING DEVICE— 510(k) K844866

Name: FDA 510(k) clearance K844866
Creator: U.S. Food and Drug Administration
Published: 1985-04-03

Substantially Equivalent

Nytone Medical

FDA 510(k) clearance K844866 for NYTONE ENURETIC ALARM BEDWETTING DEVICE, Substantially Equivalent on 1985-04-03. Applicant: Nytone Medical. Device class: 2.

Clearance details

Applicant: Nytone Medical
Product code: Code KPN
Device class: Class 2
Regulation: 21 CFR 876.2040
Advisory panel: Gastroenterology, Urology
Date received: 1984-12-14
Decision date: 1985-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, 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

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