Atlas FDA

SNN FLUORO NAVIGATION SYSTEM

FDA 510(k) clearance K993673 · decided 1999-12-21

Clearance details

K-number
K993673
Device name
SNN FLUORO NAVIGATION SYSTEM
Applicant
I.S.G. Technologies, Inc.
Decision
Substantially Equivalent
Date received
1999-11-01
Decision date
1999-12-21
Days to decision
50 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.