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FDA 510(k)

SPM-300

K-Number: K130322 · 2013-11-15

ApplicantBionet Co., Ltd.
Decision Date2013-11-15
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPM-300 is the device name listed in this FDA 510(k) record. The listed applicant is Bionet Co., Ltd.. It received FDA 510(k) clearance on 2013-11-15 under 510(k) number K130322. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPM-300?

SPM-300 is a medical device that received FDA 510(k) clearance on 2013-11-15. The listed applicant is Bionet Co., Ltd.. The 510(k) number is K130322.

When did SPM-300 receive FDA 510(k) clearance?

SPM-300 received FDA 510(k) clearance on 2013-11-15, under 510(k) number K130322.

Who is the listed applicant for SPM-300?

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

What is the FDA product code for SPM-300?

The FDA product code for SPM-300 is BZG.

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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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