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FDA 510(k)

TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*

K-Number: K864835 · 1987-02-11

ApplicantEisai U.S.A., Inc.
Decision Date1987-02-11
Product CodeFCD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR* is the device name listed in this FDA 510(k) record. The listed applicant is Eisai U.S.A., Inc.. It received FDA 510(k) clearance on 1987-02-11 under 510(k) number K864835. The device is classified under product code FCD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*?

TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR* is a medical device that received FDA 510(k) clearance on 1987-02-11. The listed applicant is Eisai U.S.A., Inc.. The 510(k) number is K864835.

When did TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR* receive FDA 510(k) clearance?

TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR* received FDA 510(k) clearance on 1987-02-11, under 510(k) number K864835.

Who is the listed applicant for TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*?

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

What is the FDA product code for TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*?

The FDA product code for TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR* is FCD.

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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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