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FDA 510(k)

PERMOBIL M300 / M400

K-Number: K103477 · 2011-03-03

ApplicantPermobil AB
Decision Date2011-03-03
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PERMOBIL M300 / M400 is the device name listed in this FDA 510(k) record. The listed applicant is Permobil AB. It received FDA 510(k) clearance on 2011-03-03 under 510(k) number K103477. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERMOBIL M300 / M400?

PERMOBIL M300 / M400 is a medical device that received FDA 510(k) clearance on 2011-03-03. The listed applicant is Permobil AB. The 510(k) number is K103477.

When did PERMOBIL M300 / M400 receive FDA 510(k) clearance?

PERMOBIL M300 / M400 received FDA 510(k) clearance on 2011-03-03, under 510(k) number K103477.

Who is the listed applicant for PERMOBIL M300 / M400?

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

What is the FDA product code for PERMOBIL M300 / M400?

The FDA product code for PERMOBIL M300 / M400 is ITI.

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Other records listing Permobil AB as applicant

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Related Devices (Code: ITI)

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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