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FDA 510(k)

BONAMATES SERIES

K-Number: K040650 · 2004-06-03

ApplicantBiotech One, Inc.
Decision Date2004-06-03
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONAMATES SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Biotech One, Inc.. It received FDA 510(k) clearance on 2004-06-03 under 510(k) number K040650. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONAMATES SERIES?

BONAMATES SERIES is a medical device that received FDA 510(k) clearance on 2004-06-03. The listed applicant is Biotech One, Inc.. The 510(k) number is K040650.

When did BONAMATES SERIES receive FDA 510(k) clearance?

BONAMATES SERIES received FDA 510(k) clearance on 2004-06-03, under 510(k) number K040650.

Who is the listed applicant for BONAMATES SERIES?

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

What is the FDA product code for BONAMATES SERIES?

The FDA product code for BONAMATES SERIES is JEY.

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Other records listing Biotech One, Inc. 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.

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Related Devices (Code: JEY)

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.

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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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