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FDA 510(k)

DE48-PLUS

K-Number: K123915 · 2013-04-24

ApplicantGrass Technologies, an Astro-Med, Inc. Product Gro
Decision Date2013-04-24
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DE48-PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Grass Technologies, an Astro-Med, Inc. Product Gro. It received FDA 510(k) clearance on 2013-04-24 under 510(k) number K123915. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DE48-PLUS?

DE48-PLUS is a medical device that received FDA 510(k) clearance on 2013-04-24. The listed applicant is Grass Technologies, an Astro-Med, Inc. Product Gro. The 510(k) number is K123915.

When did DE48-PLUS receive FDA 510(k) clearance?

DE48-PLUS received FDA 510(k) clearance on 2013-04-24, under 510(k) number K123915.

Who is the listed applicant for DE48-PLUS?

The FDA 510(k) record lists Grass Technologies, an Astro-Med, Inc. Product Gro as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DE48-PLUS?

The FDA product code for DE48-PLUS is GXY.

Related Devices (Code: GXY)

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.

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