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FDA 510(k)

PRODIGIT 2000

K-Number: K940999 · 1994-04-22

ApplicantCalmed Technology, Inc.
Decision Date1994-04-22
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PRODIGIT 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Calmed Technology, Inc.. It received FDA 510(k) clearance on 1994-04-22 under 510(k) number K940999. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRODIGIT 2000?

PRODIGIT 2000 is a medical device that received FDA 510(k) clearance on 1994-04-22. The listed applicant is Calmed Technology, Inc.. The 510(k) number is K940999.

When did PRODIGIT 2000 receive FDA 510(k) clearance?

PRODIGIT 2000 received FDA 510(k) clearance on 1994-04-22, under 510(k) number K940999.

Who is the listed applicant for PRODIGIT 2000?

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

What is the FDA product code for PRODIGIT 2000?

The FDA product code for PRODIGIT 2000 is EWO.

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Other records listing Calmed Technology, 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.

K950888SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRYK945689GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM)

Related Devices (Code: EWO)

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.

K234095OtoNova/OtoNova ProOtodynamicsK240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbHK191372LyraInteracoustics A/SK180287GSI CortiGrason-Stadler, Inc.

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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