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FDA 510(k)

BROADMASTER HEALTHCARE SYSTEM

K-Number: K130621 · 2013-07-30

ApplicantBroadmaster Biotech Corporation
Decision Date2013-07-30
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BROADMASTER HEALTHCARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Broadmaster Biotech Corporation. It received FDA 510(k) clearance on 2013-07-30 under 510(k) number K130621. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BROADMASTER HEALTHCARE SYSTEM?

BROADMASTER HEALTHCARE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-07-30. The listed applicant is Broadmaster Biotech Corporation. The 510(k) number is K130621.

When did BROADMASTER HEALTHCARE SYSTEM receive FDA 510(k) clearance?

BROADMASTER HEALTHCARE SYSTEM received FDA 510(k) clearance on 2013-07-30, under 510(k) number K130621.

Who is the listed applicant for BROADMASTER HEALTHCARE SYSTEM?

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

What is the FDA product code for BROADMASTER HEALTHCARE SYSTEM?

The FDA product code for BROADMASTER HEALTHCARE SYSTEM is NBW. This falls under the OB/GYN category.

Related Clinical Trials

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Other records listing Broadmaster Biotech 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.

K102316GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM

Related Devices (Code: NBW)

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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