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FDA 510(k)

ASYRA

K-Number: K023355 · 2003-06-24

ApplicantGalloway Technologies, LLC
Decision Date2003-06-24
Product CodeGZO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ASYRA is the device name listed in this FDA 510(k) record. The listed applicant is Galloway Technologies, LLC. It received FDA 510(k) clearance on 2003-06-24 under 510(k) number K023355. The device is classified under product code GZO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASYRA?

ASYRA is a medical device that received FDA 510(k) clearance on 2003-06-24. The listed applicant is Galloway Technologies, LLC. The 510(k) number is K023355.

When did ASYRA receive FDA 510(k) clearance?

ASYRA received FDA 510(k) clearance on 2003-06-24, under 510(k) number K023355.

Who is the listed applicant for ASYRA?

The FDA 510(k) record lists Galloway Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASYRA?

The FDA product code for ASYRA is GZO.

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Related Devices (Code: GZO)

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.

K131568SUDO PATHLd Technology, LLCK111308ZYTO HAND CRADLEZyto Technologies, Inc.K102166ELECTRO INTERSTITIAL SCANLd Technology, LLCK100233SUDOSCANImpeto MedicalK053004MSAS-VANTAGEBiomeridian, Int.K032935EPI-SCAN, MODEL P 100Edx Epi-Scan, Inc.

Official Source

View on FDA Database →

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

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