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FDA 510(k)

MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM

K-Number: K091070 · 2009-05-19

ApplicantSierra Scientific Instruments, Inc.
Decision Date2009-05-19
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sierra Scientific Instruments, Inc.. It received FDA 510(k) clearance on 2009-05-19 under 510(k) number K091070. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM?

MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-05-19. The listed applicant is Sierra Scientific Instruments, Inc.. The 510(k) number is K091070.

When did MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM receive FDA 510(k) clearance?

MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM received FDA 510(k) clearance on 2009-05-19, under 510(k) number K091070.

Who is the listed applicant for MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM?

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

What is the FDA product code for MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM?

The FDA product code for MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM is FFX.

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.

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Other records listing Sierra Scientific Instruments, 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.

K031169MOTILITY VISUALIZATION SYSTEM

Related Devices (Code: FFX)

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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