CUDDLE HEART -AUDITORY/VIBRATION DEVICE— 510(k) K845002

Name: FDA 510(k) clearance K845002
Creator: U.S. Food and Drug Administration
Published: 1986-04-23

Substantially Equivalent

International Purchasing Services

FDA 510(k) clearance K845002 for CUDDLE HEART -AUDITORY/VIBRATION DEVICE, Substantially Equivalent on 1986-04-23. Applicant: International Purchasing Services. Device class: 2.

Clearance details

Applicant: International Purchasing Services
Product code: Code FMS
Device class: Class 2
Regulation: 21 CFR 880.5140
Advisory panel: General Hospital
Date received: 1984-12-26
Decision date: 1986-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newbury Park, CA, US

Download summary PDF View on FDA.gov ↗

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