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FDA 510(k)

MOBIS II

K-Number: K131372 · 2013-07-02

ApplicantSignus Medizintechnik GmbH
Decision Date2013-07-02
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MOBIS II is the device name listed in this FDA 510(k) record. The listed applicant is Signus Medizintechnik GmbH. It received FDA 510(k) clearance on 2013-07-02 under 510(k) number K131372. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOBIS II?

MOBIS II is a medical device that received FDA 510(k) clearance on 2013-07-02. The listed applicant is Signus Medizintechnik GmbH. The 510(k) number is K131372.

When did MOBIS II receive FDA 510(k) clearance?

MOBIS II received FDA 510(k) clearance on 2013-07-02, under 510(k) number K131372.

Who is the listed applicant for MOBIS II?

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

What is the FDA product code for MOBIS II?

The FDA product code for MOBIS II is MAX.

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Other records listing Signus Medizintechnik GmbH as applicant

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Related Devices (Code: MAX)

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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