FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

MEA110

K Number: K843822 · Decision Oct 22, 1984
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
2
Review Days
24

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
MEA110
K Number
K843822
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.5890
Medical Specialty
Neurology
Decision
Substantially Equivalent
Applicant
Canadian Medical Products
Date Received
September 28, 1984
Decision Date
October 22, 1984
Product Code
GZJ
Advisory Committee
Neurology
Review Advisory Committee
NE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (GZJ), ordered by most recent decision date.

View all

Other Clearances by Canadian Medical Products

K Number Device Name
K820326 BIGSTON TRANSCUTANEOUS NERVE STIMULAT