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FDA 510(k)

BEL-CYPHER, MODEL Y977

K-Number: K090020 · 2009-03-13

Decision Date2009-03-13
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BEL-CYPHER, MODEL Y977 is the device name listed in this FDA 510(k) record. The listed applicant is Takara-Belmont Co., Ltd.. It received FDA 510(k) clearance on 2009-03-13 under 510(k) number K090020. 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, MODEL Y977?

BEL-CYPHER, MODEL Y977 is a medical device that received FDA 510(k) clearance on 2009-03-13. The listed applicant is Takara-Belmont Co., Ltd.. The 510(k) number is K090020.

When did BEL-CYPHER, MODEL Y977 receive FDA 510(k) clearance?

BEL-CYPHER, MODEL Y977 received FDA 510(k) clearance on 2009-03-13, under 510(k) number K090020.

Who is the listed applicant for BEL-CYPHER, MODEL Y977?

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

What is the FDA product code for BEL-CYPHER, MODEL Y977?

The FDA product code for BEL-CYPHER, MODEL Y977 is MUH.

Related Clinical Trials

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

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