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FDA 510(k)

MEMORY PUMP MODEL Y4947

K-Number: K131027 · 2013-05-30

ApplicantTomy International
Decision Date2013-05-30
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MEMORY PUMP MODEL Y4947 is the device name listed in this FDA 510(k) record. The listed applicant is Tomy International. It received FDA 510(k) clearance on 2013-05-30 under 510(k) number K131027. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEMORY PUMP MODEL Y4947?

MEMORY PUMP MODEL Y4947 is a medical device that received FDA 510(k) clearance on 2013-05-30. The listed applicant is Tomy International. The 510(k) number is K131027.

When did MEMORY PUMP MODEL Y4947 receive FDA 510(k) clearance?

MEMORY PUMP MODEL Y4947 received FDA 510(k) clearance on 2013-05-30, under 510(k) number K131027.

Who is the listed applicant for MEMORY PUMP MODEL Y4947?

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

What is the FDA product code for MEMORY PUMP MODEL Y4947?

The FDA product code for MEMORY PUMP MODEL Y4947 is HGX.

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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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