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FDA 510(k)

DIGITEST

K-Number: K950237 · 1995-06-09

ApplicantParkell, Inc.
Decision Date1995-06-09
Product CodeEAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIGITEST is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 1995-06-09 under 510(k) number K950237. The device is classified under product code EAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITEST?

DIGITEST is a medical device that received FDA 510(k) clearance on 1995-06-09. The listed applicant is Parkell, Inc.. The 510(k) number is K950237.

When did DIGITEST receive FDA 510(k) clearance?

DIGITEST received FDA 510(k) clearance on 1995-06-09, under 510(k) number K950237.

Who is the listed applicant for DIGITEST?

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

What is the FDA product code for DIGITEST?

The FDA product code for DIGITEST is EAT.

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Other records listing Parkell, Inc. as applicant

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Related Devices (Code: EAT)

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

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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