Vectorvision Hip

FDA 510(k) K060727 · Brainlab AG

Substantially Equivalent

510(k) numberK060727

Submission

Device name
Vectorvision Hip
Applicant
Brainlab AG
Heimstetten, DE
Received
March 17, 2006
Decision date
August 21, 2006
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HAW – Neurological Stereotaxic Instrument
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4560
Specialty
Neurology

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Questions and answers

When was Vectorvision Hip cleared by the FDA?

Vectorvision Hip (K060727) received a 510(k) decision of Substantially Equivalent on August 21, 2006, 157 days after the submission was received.

What is the product code of K060727?

The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.