SOFWAVE MEDICAL LTD

Address:HaOtsma 1,Yokneam Illit Northern,IL

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption (OHV) (3)

Premarket Exempt

Clear

Sofwave - 07290018152003 Catalog Number : FG00001

Device Description : FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION

Device Class : 2

Duns Number: 531962539

Premarket Exempt : No

Product Code : OHV

Prescription Use : No

Device Count : 1

Sofwave Applicator - 07290018152010 Catalog Number : FG00002

Device Class : 2

Duns Number: 531962539

Premarket Exempt : No

Product Code : OHV

Prescription Use : No

Device Count : 1

Sofwave Applicator - 07290018152027 Catalog Number : FG00002-R

Device Class : 2

Duns Number: 531962539

Premarket Exempt : No

Product Code : OHV

Prescription Use : No

Device Count : 1

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