The following data is part of a premarket notification filed by Chemfet Corp. with the FDA for Portable Ph, Mv, Temp Meter W/auto. Temp Compensa..
Device ID | K871922 |
510k Number | K871922 |
Device Name: | PORTABLE PH, MV, TEMP METER W/AUTO. TEMP COMPENSA. |
Classification | Electrode, Ph, Stomach |
Applicant | CHEMFET CORP. 777-108TH AVE. N.E. (1200) RAINIER BANK PLAZA Bellevue, WA 98004 |
Contact | Lori Cadwell |
Correspondent | Lori Cadwell CHEMFET CORP. 777-108TH AVE. N.E. (1200) RAINIER BANK PLAZA Bellevue, WA 98004 |
Product Code | FFT |
CFR Regulation Number | 876.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-18 |
Decision Date | 1987-10-20 |