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FDA 510(k)

SINGLE DOSE GAS INJECTOR

K-Number: K923397 · 1992-09-14

ApplicantEscalon Medical Trek
Decision Date1992-09-14
Product CodeBXX
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SINGLE DOSE GAS INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Escalon Medical Trek. It received FDA 510(k) clearance on 1992-09-14 under 510(k) number K923397. The device is classified under product code BXX. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE DOSE GAS INJECTOR?

SINGLE DOSE GAS INJECTOR is a medical device that received FDA 510(k) clearance on 1992-09-14. The listed applicant is Escalon Medical Trek. The 510(k) number is K923397.

When did SINGLE DOSE GAS INJECTOR receive FDA 510(k) clearance?

SINGLE DOSE GAS INJECTOR received FDA 510(k) clearance on 1992-09-14, under 510(k) number K923397.

Who is the listed applicant for SINGLE DOSE GAS INJECTOR?

The FDA 510(k) record lists Escalon Medical Trek as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGLE DOSE GAS INJECTOR?

The FDA product code for SINGLE DOSE GAS INJECTOR is BXX.

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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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