Vectorvision Cranial, Vectorvision ENT, Kolibri Cranial, Kolibri ENT, Cranial Essential, Cranial Unlimited
FDA 510(k) K092467 · Brainlab AG
510(k) numberK092467
Submission
- Device name
- Vectorvision Cranial, Vectorvision ENT, Kolibri Cranial, Kolibri ENT, Cranial Essential, Cranial Unlimited
- Applicant
- Brainlab AG
Feldkirchen, DE - Received
- August 12, 2009
- Decision date
- May 6, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Vectorvision Cranial, Vectorvision ENT, Kolibri Cranial, Kolibri ENT, Cranial Essential, Cranial Unlimited cleared by the FDA?
Vectorvision Cranial, Vectorvision ENT, Kolibri Cranial, Kolibri ENT, Cranial Essential, Cranial Unlimited (K092467) received a 510(k) decision of Substantially Equivalent on May 6, 2010, 267 days after the submission was received.
What is the product code of K092467?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.