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FDA 510(k)

BIO-MAT 2000

K-Number: K072534 · 2008-02-08

ApplicantRichway Intl., Inc.
Decision Date2008-02-08
Product CodeIRT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIO-MAT 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Richway Intl., Inc.. It received FDA 510(k) clearance on 2008-02-08 under 510(k) number K072534. The device is classified under product code IRT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-MAT 2000?

BIO-MAT 2000 is a medical device that received FDA 510(k) clearance on 2008-02-08. The listed applicant is Richway Intl., Inc.. The 510(k) number is K072534.

When did BIO-MAT 2000 receive FDA 510(k) clearance?

BIO-MAT 2000 received FDA 510(k) clearance on 2008-02-08, under 510(k) number K072534.

Who is the listed applicant for BIO-MAT 2000?

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

What is the FDA product code for BIO-MAT 2000?

The FDA product code for BIO-MAT 2000 is IRT.

Related Devices (Code: IRT)

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

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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