FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

MENTOR 150 PLUS TRANSCUTANEOUS ELEC.

K Number: K842812 · Decision Aug 8, 1984
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
61
Review Days
21

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
MENTOR 150 PLUS TRANSCUTANEOUS ELEC.
K Number
K842812
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.5890
Medical Specialty
Neurology
Decision
Substantially Equivalent
Applicant
Mentor Corp.
Date Received
July 18, 1984
Decision Date
August 8, 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 Mentor Corp.

K Number Device Name
K130813 MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS
K053414 MENTOR NOVASILK MESH
K050008 MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
K042851 MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT
K040959 MENTOR GENESIS PENILE PROSTHESIS
K031767 MENTOR OBTAPE TRANS-OBTURATOR TAPE
K011493 MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY
K011500 MENTOR CONTOUR PROFILE TISSUE EXPANDER
K004005 MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED)
K010709 MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
Search all 61 clearances from Mentor Corp. →