ISG FAMILY OF VIEWING WANDS
FDA 510(k) clearance K970865 · decided 1997-06-04
Clearance details
- K-number
- K970865
- Device name
- ISG FAMILY OF VIEWING WANDS
- Applicant
- I.S.G. Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-03-10
- Decision date
- 1997-06-04
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mississauga Ontario, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.