MICROTARGETING GUIDELINE 4000
FDA 510(k) clearance K071364 · decided 2007-07-25
Clearance details
- K-number
- K071364
- Device name
- MICROTARGETING GUIDELINE 4000
- Applicant
- FHC, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-05-16
- Decision date
- 2007-07-25
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- GZL
- Device class
- 2
- Regulation number
- 882.1330
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Bowdoin, ME, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, Catalog # MT-GL4K. Intended to recall (Z-1143-2010) | FHC, Inc. | 2010-03-16 |