FDA 510(k)

BABY POD

K-Number: K030283 · 2003-04-22

Decision Date2003-04-22

Product CodeFPP

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BABY POD is the device name listed in this FDA 510(k) record. The listed applicant is Prism Enterprises, Inc.. It received FDA 510(k) clearance on 2003-04-22 under 510(k) number K030283. The device is classified under product code FPP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BABY POD?

BABY POD is a medical device that received FDA 510(k) clearance on 2003-04-22. The listed applicant is Prism Enterprises, Inc.. The 510(k) number is K030283.

When did BABY POD receive FDA 510(k) clearance?

BABY POD received FDA 510(k) clearance on 2003-04-22, under 510(k) number K030283.

Who is the listed applicant for BABY POD?

The FDA 510(k) record lists Prism Enterprises, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BABY POD?

The FDA product code for BABY POD is FPP.

Other records listing Prism Enterprises, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.