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FDA 510(k)

STIWELL MED4

K-Number: K080950 · 2009-04-02

ApplicantOtto Bock, Austria GmbH
Decision Date2009-04-02
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STIWELL MED4 is the device name listed in this FDA 510(k) record. The listed applicant is Otto Bock, Austria GmbH. It received FDA 510(k) clearance on 2009-04-02 under 510(k) number K080950. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STIWELL MED4?

STIWELL MED4 is a medical device that received FDA 510(k) clearance on 2009-04-02. The listed applicant is Otto Bock, Austria GmbH. The 510(k) number is K080950.

When did STIWELL MED4 receive FDA 510(k) clearance?

STIWELL MED4 received FDA 510(k) clearance on 2009-04-02, under 510(k) number K080950.

Who is the listed applicant for STIWELL MED4?

The FDA 510(k) record lists Otto Bock, Austria GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STIWELL MED4?

The FDA product code for STIWELL MED4 is IPF.

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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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