FHC Microtargeting Drive System
FDA 510(k) K011992 · FHC, Inc.
510(k) numberK011992
Submission
- Device name
- FHC Microtargeting Drive System
- Applicant
- FHC, Inc.
Bowdoinham, ME, US - Received
- June 26, 2001
- Decision date
- August 14, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was FHC Microtargeting Drive System cleared by the FDA?
FHC Microtargeting Drive System (K011992) received a 510(k) decision of Substantially Equivalent on August 14, 2001, 49 days after the submission was received.
What is the product code of K011992?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.