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FDA 510(k)

PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES

K-Number: K120065 · 2012-04-03

ApplicantPlaxtron Industrial (M) Sdn. Bhd.
Decision Date2012-04-03
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Plaxtron Industrial (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2012-04-03 under 510(k) number K120065. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES?

PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES is a medical device that received FDA 510(k) clearance on 2012-04-03. The listed applicant is Plaxtron Industrial (M) Sdn. Bhd.. The 510(k) number is K120065.

When did PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES receive FDA 510(k) clearance?

PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES received FDA 510(k) clearance on 2012-04-03, under 510(k) number K120065.

Who is the listed applicant for PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES?

The FDA 510(k) record lists Plaxtron Industrial (M) Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES?

The FDA product code for PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES is JCX.

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Related Devices (Code: JCX)

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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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