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FDA 510(k)

MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025

K-Number: K092919 · 2009-10-23

Decision Date2009-10-23
Product CodeLON
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2009-10-23 under 510(k) number K092919. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025?

MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025 is a medical device that received FDA 510(k) clearance on 2009-10-23. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K092919.

When did MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025 receive FDA 510(k) clearance?

MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025 received FDA 510(k) clearance on 2009-10-23, under 510(k) number K092919.

Who is the listed applicant for MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025?

The FDA product code for MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025 is LON.

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.

Other records listing Siemens Healthcare Diagnostics 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: LON)

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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