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FDA 510(k)

EKG, SWITCHING BLADE AND PENS

K-Number: K781799 · 1979-02-26

ApplicantBionex, Inc.
Decision Date1979-02-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EKG, SWITCHING BLADE AND PENS is the device name listed in this FDA 510(k) record. The listed applicant is Bionex, Inc.. It received FDA 510(k) clearance on 1979-02-26 under 510(k) number K781799. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EKG, SWITCHING BLADE AND PENS?

EKG, SWITCHING BLADE AND PENS is a medical device that received FDA 510(k) clearance on 1979-02-26. The listed applicant is Bionex, Inc.. The 510(k) number is K781799.

When did EKG, SWITCHING BLADE AND PENS receive FDA 510(k) clearance?

EKG, SWITCHING BLADE AND PENS received FDA 510(k) clearance on 1979-02-26, under 510(k) number K781799.

Who is the listed applicant for EKG, SWITCHING BLADE AND PENS?

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

What is the FDA product code for EKG, SWITCHING BLADE AND PENS?

The FDA product code for EKG, SWITCHING BLADE AND PENS is GEI.

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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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