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FDA 510(k)

MEGAVISION CPX, MEGAVISION FA, MODEL I AND II

K-Number: K002920 · 2000-12-18

ApplicantEscalon Medical Corp.
Decision Date2000-12-18
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MEGAVISION CPX, MEGAVISION FA, MODEL I AND II is the device name listed in this FDA 510(k) record. The listed applicant is Escalon Medical Corp.. It received FDA 510(k) clearance on 2000-12-18 under 510(k) number K002920. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEGAVISION CPX, MEGAVISION FA, MODEL I AND II?

MEGAVISION CPX, MEGAVISION FA, MODEL I AND II is a medical device that received FDA 510(k) clearance on 2000-12-18. The listed applicant is Escalon Medical Corp.. The 510(k) number is K002920.

When did MEGAVISION CPX, MEGAVISION FA, MODEL I AND II receive FDA 510(k) clearance?

MEGAVISION CPX, MEGAVISION FA, MODEL I AND II received FDA 510(k) clearance on 2000-12-18, under 510(k) number K002920.

Who is the listed applicant for MEGAVISION CPX, MEGAVISION FA, MODEL I AND II?

The FDA 510(k) record lists Escalon Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEGAVISION CPX, MEGAVISION FA, MODEL I AND II?

The FDA product code for MEGAVISION CPX, MEGAVISION FA, MODEL I AND II is HKI.

Related Clinical Trials

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Other records listing Escalon Medical Corp. 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.

K093613VASCUVIEW TAP ULTRASOUND SYSTEMK080049VASCUVIEW ULTRASOUND SYSTEM

Related Devices (Code: HKI)

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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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