PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS— 510(k) K844176

Name: FDA 510(k) clearance K844176
Creator: U.S. Food and Drug Administration
Published: 1985-01-23

Substantially Equivalent

Premie Comfort Products

FDA 510(k) clearance K844176 for PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS, Substantially Equivalent on 1985-01-23. Applicant: Premie Comfort Products. Device class: 1.

Clearance details

Applicant: Premie Comfort Products
Product code: Code FRP
Device class: Class 1
Regulation: 21 CFR 880.5680
Advisory panel: General Hospital
Date received: 1984-10-25
Decision date: 1985-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRP

view all

K082367 — INFANT SLEEP BEANIE2009-06-12
K090284 — RES-Q INFANT WEDGE AND SLING2009-06-05
K062143 — KOZY COMFORT INFANT POSITIONER2006-10-24
K060986 — HEAD BED2006-07-11
K051300 — ROBIN HOOD VEST2005-12-08

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