Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K161502
Device Classification Name
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
More FDA Info for this Device
510(K) Number
K161502
Device Name
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant
GENERAL PROJECT S.R.L.
VIA DELLA GORA 15/19
MONTESPERTOLI 50025 IT
Other 510(k) Applications for this Company
Contact
MORENO NALDONI
Other 510(k) Applications for this Contact
Regulation Number
890.5300
More FDA Info for this Regulation Number
Classification Product Code
IMI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/01/2016
Decision Date
08/16/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact