BABY POD— 510(k) K030283

Substantially Equivalent

Prism Enterprises, Inc.

FDA 510(k) clearance K030283 for BABY POD, Substantially Equivalent on 2003-04-22. Applicant: Prism Enterprises, Inc.. Device class: 1.

Clearance details

Applicant: Prism Enterprises, Inc.
Product code: Code FPP
Device class: Class 1
Regulation: 21 CFR 880.6900
Advisory panel: General Hospital
Date received: 2003-01-27
Decision date: 2003-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FPP

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K940130 — STRYKER MODEL 6110 EMERGENCY/POLE STRETCHER1994-03-10
K940245 — EVACU-SLED1994-02-28
K924275 — RESTRAINING STRETCHER1993-07-27
K922816 — U P CUSTOM DESIGN, INC. COT EQUIPMENT CARRIER1993-07-13

More clearances from Prism Enterprises, Inc.

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K000444 — MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM2000-04-21

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