Class I - Dangerous
Lack of 510(k) clearance.
Lack of 510(k) clearance.
Lack of 510(k) clearance.
Lack of 510(k) clearance.
Lack of 510(k) clearance.
Lack of 510(k) clearance.
Lack of 510(k) clearance.
Lack of 510(k) clearance.
Lack of 510(k) clearance.