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FDA 510(k)

Bel-Cypher Pro

K-Number: K163175 · 2017-03-20

Decision Date2017-03-20
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bel-Cypher Pro is the device name listed in this FDA 510(k) record. The listed applicant is Takara Belmont Corporation. It received FDA 510(k) clearance on 2017-03-20 under 510(k) number K163175. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bel-Cypher Pro?

Bel-Cypher Pro is a medical device that received FDA 510(k) clearance on 2017-03-20. The listed applicant is Takara Belmont Corporation. The 510(k) number is K163175.

When did Bel-Cypher Pro receive FDA 510(k) clearance?

Bel-Cypher Pro received FDA 510(k) clearance on 2017-03-20, under 510(k) number K163175.

Who is the listed applicant for Bel-Cypher Pro?

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

What is the FDA product code for Bel-Cypher Pro?

The FDA product code for Bel-Cypher Pro is MUH.

Other records listing Takara Belmont Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: MUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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