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FDA 510(k)

DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS

K-Number: K980509 · 1998-02-26

Decision Date1998-02-26
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 1998-02-26 under 510(k) number K980509. The device is classified under product code IMD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS?

DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS is a medical device that received FDA 510(k) clearance on 1998-02-26. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K980509.

When did DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS receive FDA 510(k) clearance?

DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS received FDA 510(k) clearance on 1998-02-26, under 510(k) number K980509.

Who is the listed applicant for DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS?

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

What is the FDA product code for DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS?

The FDA product code for DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS is IMD.

Related Clinical Trials

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.

Other records listing Deroyal Industries, 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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Related Devices (Code: IMD)

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.

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.

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