Atlas FDA

MYOSCIENCE CRYO-TOUCH

FDA 510(k) clearance K100447 · decided 2010-06-25

Clearance details

K-number
K100447
Device name
MYOSCIENCE CRYO-TOUCH
Applicant
Myoscience, Inc.
Decision
Substantially Equivalent
Date received
2010-02-17
Decision date
2010-06-25
Days to decision
128 days
Clearance type
Traditional
Product code
GXH
Device class
2
Regulation number
882.4250
Medical specialty
Neurology
Advisory committee
Neurology
Location
Redwood City, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.