Microtargeting Drive System
FDA 510(k) K003776 · FHC, Inc.
510(k) numberK003776
Submission
- Device name
- Microtargeting Drive System
- Applicant
- FHC, Inc.
Bowdoinham, ME, US - Received
- December 7, 2000
- Decision date
- February 23, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Microtargeting Drive System cleared by the FDA?
Microtargeting Drive System (K003776) received a 510(k) decision of Substantially Equivalent on February 23, 2001, 78 days after the submission was received.
What is the product code of K003776?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.