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FDA 510(k)

VOLTERA POWERED SUCTION PUMP

K-Number: K112853 · 2012-11-09

ApplicantSuzric Enterprise Co., Ltd.
Decision Date2012-11-09
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VOLTERA POWERED SUCTION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Suzric Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2012-11-09 under 510(k) number K112853. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOLTERA POWERED SUCTION PUMP?

VOLTERA POWERED SUCTION PUMP is a medical device that received FDA 510(k) clearance on 2012-11-09. The listed applicant is Suzric Enterprise Co., Ltd.. The 510(k) number is K112853.

When did VOLTERA POWERED SUCTION PUMP receive FDA 510(k) clearance?

VOLTERA POWERED SUCTION PUMP received FDA 510(k) clearance on 2012-11-09, under 510(k) number K112853.

Who is the listed applicant for VOLTERA POWERED SUCTION PUMP?

The FDA 510(k) record lists Suzric Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VOLTERA POWERED SUCTION PUMP?

The FDA product code for VOLTERA POWERED SUCTION PUMP is OMP.

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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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