The following data is part of a premarket notification filed by World Precision Instruments, Inc. with the FDA for Model Sa3 Esophageal Ph Electrode.
| Device ID | K852289 |
| 510k Number | K852289 |
| Device Name: | MODEL SA3 ESOPHAGEAL PH ELECTRODE |
| Classification | Electrode, Ph, Stomach |
| Applicant | WORLD PRECISION INSTRUMENTS, INC. 375 QUINNIPIAC AVE. New Haven, CT 06513 |
| Contact | Janet B Fein |
| Correspondent | Janet B Fein WORLD PRECISION INSTRUMENTS, INC. 375 QUINNIPIAC AVE. New Haven, CT 06513 |
| Product Code | FFT |
| CFR Regulation Number | 876.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-29 |
| Decision Date | 1985-07-25 |