FHC MICROTARGETING DRIVE SYSTEM
FDA 510(k) clearance K011992 · decided 2001-08-14
Clearance details
- K-number
- K011992
- Device name
- FHC MICROTARGETING DRIVE SYSTEM
- Applicant
- FHC, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-06-26
- Decision date
- 2001-08-14
- Days to decision
- 49 days
- Clearance type
- Special
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Bowdoinham, ME, US
- Third-party review
- No
- Expedited review
- No
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