FDA 510(k)

SEER 1000

K-Number: K130785 · 2013-07-26

ApplicantGetemed Medizin- Und Informationstechnik AG

Decision Date2013-07-26

Product CodeMWJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SEER 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Getemed Medizin- Und Informationstechnik AG. It received FDA 510(k) clearance on 2013-07-26 under 510(k) number K130785. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEER 1000?

SEER 1000 is a medical device that received FDA 510(k) clearance on 2013-07-26. The listed applicant is Getemed Medizin- Und Informationstechnik AG. The 510(k) number is K130785.

When did SEER 1000 receive FDA 510(k) clearance?

SEER 1000 received FDA 510(k) clearance on 2013-07-26, under 510(k) number K130785.

Who is the listed applicant for SEER 1000?

The FDA 510(k) record lists Getemed Medizin- Und Informationstechnik AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEER 1000?

The FDA product code for SEER 1000 is MWJ.

Other records listing Getemed Medizin- Und Informationstechnik AG as applicant

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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.