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FDA 510(k)

MYOSYSTEM WITH CUSTOMIZING

K-Number: K032833 · 2003-09-23

ApplicantOtto Bock Healthcare LP
Decision Date2003-09-23
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MYOSYSTEM WITH CUSTOMIZING is the device name listed in this FDA 510(k) record. The listed applicant is Otto Bock Healthcare LP. It received FDA 510(k) clearance on 2003-09-23 under 510(k) number K032833. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYOSYSTEM WITH CUSTOMIZING?

MYOSYSTEM WITH CUSTOMIZING is a medical device that received FDA 510(k) clearance on 2003-09-23. The listed applicant is Otto Bock Healthcare LP. The 510(k) number is K032833.

When did MYOSYSTEM WITH CUSTOMIZING receive FDA 510(k) clearance?

MYOSYSTEM WITH CUSTOMIZING received FDA 510(k) clearance on 2003-09-23, under 510(k) number K032833.

Who is the listed applicant for MYOSYSTEM WITH CUSTOMIZING?

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

What is the FDA product code for MYOSYSTEM WITH CUSTOMIZING?

The FDA product code for MYOSYSTEM WITH CUSTOMIZING is GXY.

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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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