Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K961212
Device Classification Name
Goniometer, Ac-Powered
More FDA Info for this Device
510(K) Number
K961212
Device Name
Goniometer, Ac-Powered
Applicant
FASSTECH
155 MIDDLESEX TURNPIKE
BURLINGTON, MA 01803 US
Other 510(k) Applications for this Company
Contact
LEE R BRODY
Other 510(k) Applications for this Contact
Regulation Number
888.1500
More FDA Info for this Regulation Number
Classification Product Code
KQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/28/1996
Decision Date
06/12/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact