Atlas FDA

CRYO-TOUCH III

FDA 510(k) clearance K120415 · decided 2012-06-22

Clearance details

K-number
K120415
Device name
CRYO-TOUCH III
Applicant
Myoscience, Inc.
Decision
Substantially Equivalent
Date received
2012-02-10
Decision date
2012-06-22
Days to decision
133 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.