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FDA 510(k)

RX EVEREST

K-Number: K001051 · 2000-04-28

ApplicantJeneric/Pentron, Inc.
Decision Date2000-04-28
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RX EVEREST is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric/Pentron, Inc.. It received FDA 510(k) clearance on 2000-04-28 under 510(k) number K001051. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RX EVEREST?

RX EVEREST is a medical device that received FDA 510(k) clearance on 2000-04-28. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K001051.

When did RX EVEREST receive FDA 510(k) clearance?

RX EVEREST received FDA 510(k) clearance on 2000-04-28, under 510(k) number K001051.

Who is the listed applicant for RX EVEREST?

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

What is the FDA product code for RX EVEREST?

The FDA product code for RX EVEREST is EJT.

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Other records listing Jeneric/Pentron, Inc. as applicant

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Related Devices (Code: EJT)

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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