RFG-3CF
FDA 510(k) clearance K965182 · decided 1997-03-12
Clearance details
- K-number
- K965182
- Device name
- RFG-3CF
- Applicant
- Radionics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-24
- Decision date
- 1997-03-12
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- GXD
- Device class
- 2
- Regulation number
- 882.4400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Burlington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.