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FDA 510(k)

J-SCOPE SYSTEM

K-Number: K122411 · 2013-02-11

ApplicantMyelotec
Decision Date2013-02-11
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

J-SCOPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Myelotec. It received FDA 510(k) clearance on 2013-02-11 under 510(k) number K122411. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the J-SCOPE SYSTEM?

J-SCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-02-11. The listed applicant is Myelotec. The 510(k) number is K122411.

When did J-SCOPE SYSTEM receive FDA 510(k) clearance?

J-SCOPE SYSTEM received FDA 510(k) clearance on 2013-02-11, under 510(k) number K122411.

Who is the listed applicant for J-SCOPE SYSTEM?

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

What is the FDA product code for J-SCOPE SYSTEM?

The FDA product code for J-SCOPE SYSTEM is HRX.

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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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