The following data is part of a premarket notification filed by Chemfet Corp. with the FDA for General Purpose Combination Ph Electrode.
| Device ID | K871921 |
| 510k Number | K871921 |
| Device Name: | GENERAL PURPOSE COMBINATION PH ELECTRODE |
| 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 |