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FDA 510(k)

INREACH SYSTEM, MODEL AAS00161-02

K-Number: K092365 · 2009-09-04

ApplicantSuperdimension, Ltd.
Decision Date2009-09-04
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INREACH SYSTEM, MODEL AAS00161-02 is the device name listed in this FDA 510(k) record. The listed applicant is Superdimension, Ltd.. It received FDA 510(k) clearance on 2009-09-04 under 510(k) number K092365. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INREACH SYSTEM, MODEL AAS00161-02?

INREACH SYSTEM, MODEL AAS00161-02 is a medical device that received FDA 510(k) clearance on 2009-09-04. The listed applicant is Superdimension, Ltd.. The 510(k) number is K092365.

When did INREACH SYSTEM, MODEL AAS00161-02 receive FDA 510(k) clearance?

INREACH SYSTEM, MODEL AAS00161-02 received FDA 510(k) clearance on 2009-09-04, under 510(k) number K092365.

Who is the listed applicant for INREACH SYSTEM, MODEL AAS00161-02?

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

What is the FDA product code for INREACH SYSTEM, MODEL AAS00161-02?

The FDA product code for INREACH SYSTEM, MODEL AAS00161-02 is JAK.

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Other records listing Superdimension, Ltd. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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