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FDA 510(k)

GENTAL PULSE

K-Number: K950238 · 1995-05-09

ApplicantParkell, Inc.
Decision Date1995-05-09
Product CodeEAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GENTAL PULSE is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 1995-05-09 under 510(k) number K950238. 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 GENTAL PULSE?

GENTAL PULSE is a medical device that received FDA 510(k) clearance on 1995-05-09. The listed applicant is Parkell, Inc.. The 510(k) number is K950238.

When did GENTAL PULSE receive FDA 510(k) clearance?

GENTAL PULSE received FDA 510(k) clearance on 1995-05-09, under 510(k) number K950238.

Who is the listed applicant for GENTAL PULSE?

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 GENTAL PULSE?

The FDA product code for GENTAL PULSE 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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