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FDA 510(k)

DASH HIP

K-Number: K110021 · 2011-10-18

ApplicantBrainlab AG
Decision Date2011-10-18
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DASH HIP is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2011-10-18 under 510(k) number K110021. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DASH HIP?

DASH HIP is a medical device that received FDA 510(k) clearance on 2011-10-18. The listed applicant is Brainlab AG. The 510(k) number is K110021.

When did DASH HIP receive FDA 510(k) clearance?

DASH HIP received FDA 510(k) clearance on 2011-10-18, under 510(k) number K110021.

Who is the listed applicant for DASH HIP?

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

What is the FDA product code for DASH HIP?

The FDA product code for DASH HIP is OLO.

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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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