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

MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT

K Number: K780932 · Decision Aug 31, 1978
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
12
Applicant Total
7
Review Days
86

Basic Information

Device Name
MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT
K Number
K780932
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.5820
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Applicant
WESTERN LABORATORIES CORP.
Date Received
June 6, 1978
Decision Date
August 31, 1978
Product Code
FIZ
Advisory Committee
Gastroenterology, Urology
Review Advisory Committee
GU
Third Party
N

Classifications

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

Product Code Device Name
FIZ Meter, Conductivity, Non-Remote

Similar 510(k) Clearances

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

View all

Other Clearances by WESTERN LABORATORIES CORP.

K Number Device Name
K834024 HEPARINOMETER
K830468 MODEL 200
K821834 MODEL 100 BICARBONATE CONDUCTIVITY
K821414 MODEL 80 BC
K821415 MODEL 90 BC
K801303 MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST