FDA 510(k)

LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE

K-Number: K851402 · 1985-06-10

Decision Date1985-06-10

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Tech, Inc.. It received FDA 510(k) clearance on 1985-06-10 under 510(k) number K851402. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE?

LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE is a medical device that received FDA 510(k) clearance on 1985-06-10. The listed applicant is Medi-Tech, Inc.. The 510(k) number is K851402.

When did LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE receive FDA 510(k) clearance?

LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE received FDA 510(k) clearance on 1985-06-10, under 510(k) number K851402.

Who is the listed applicant for LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE?

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

What is the FDA product code for LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE?

The FDA product code for LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE is DXT.

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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.