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FDA 510(k)

M-SCAN

K-Number: K130158 · 2013-07-25

ApplicantBio-Research Associates, Inc.
Decision Date2013-07-25
Product CodeKZM
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

M-SCAN is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Research Associates, Inc.. It received FDA 510(k) clearance on 2013-07-25 under 510(k) number K130158. The device is classified under product code KZM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M-SCAN?

M-SCAN is a medical device that received FDA 510(k) clearance on 2013-07-25. The listed applicant is Bio-Research Associates, Inc.. The 510(k) number is K130158.

When did M-SCAN receive FDA 510(k) clearance?

M-SCAN received FDA 510(k) clearance on 2013-07-25, under 510(k) number K130158.

Who is the listed applicant for M-SCAN?

The FDA 510(k) record lists Bio-Research Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M-SCAN?

The FDA product code for M-SCAN is KZM.

Other records listing Bio-Research Associates, 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.

K082927BIOEMG IIIK061799QUADRATENS, MODEL QT-42K003176BIOEMG II AND BIOJVAK9917563 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPEK981563BIOPAK MEASUREMENT SYSTEMK952218JT-3 ELECTROGNATHOGRAPH

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Related Devices (Code: KZM)

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.

K161716TEETHAN 2.0Bts S.P.A.K113677GRINDCARE MEASUREMedotech A/SK082927BIOEMG IIIBio-Research Associates, Inc.K043373DOLOTENS DENTAL TM 1Neuromuscular Technologies, Inc.K030869BITESTRIPS.L.P. , Ltd.K003176BIOEMG II AND BIOJVABio-Research Associates, Inc.

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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