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FDA 510(k)

EPI-SCAN, MODEL P 100

K-Number: K032935 · 2003-11-20

ApplicantEdx Epi-Scan, Inc.
Decision Date2003-11-20
Product CodeGZO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EPI-SCAN, MODEL P 100 is the device name listed in this FDA 510(k) record. The listed applicant is Edx Epi-Scan, Inc.. It received FDA 510(k) clearance on 2003-11-20 under 510(k) number K032935. 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 EPI-SCAN, MODEL P 100?

EPI-SCAN, MODEL P 100 is a medical device that received FDA 510(k) clearance on 2003-11-20. The listed applicant is Edx Epi-Scan, Inc.. The 510(k) number is K032935.

When did EPI-SCAN, MODEL P 100 receive FDA 510(k) clearance?

EPI-SCAN, MODEL P 100 received FDA 510(k) clearance on 2003-11-20, under 510(k) number K032935.

Who is the listed applicant for EPI-SCAN, MODEL P 100?

The FDA 510(k) record lists Edx Epi-Scan, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPI-SCAN, MODEL P 100?

The FDA product code for EPI-SCAN, MODEL P 100 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.K023355ASYRAGalloway Technologies, LLC

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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