NEONATAL RESTRAINT AND COMFORT SYSTEMS— 510(k) K943017

Name: FDA 510(k) clearance K943017
Creator: U.S. Food and Drug Administration
Published: 1995-01-19

Substantially Equivalent

K.Bowmed, Inc.

FDA 510(k) clearance K943017 for NEONATAL RESTRAINT AND COMFORT SYSTEMS, Substantially Equivalent on 1995-01-19. Applicant: K.Bowmed, Inc.. Device class: 1.

Clearance details

Applicant: K.Bowmed, Inc.
Product code: Code FRP
Device class: Class 1
Regulation: 21 CFR 880.5680
Advisory panel: General Hospital
Date received: 1994-06-24
Decision date: 1995-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Wilkesboro, NC, US

Download summary PDF View on FDA.gov ↗

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