The following data is part of a premarket notification filed by Zinetics Medical Technology Corp. with the FDA for Zinetics Gastrometer (tm).
| Device ID | K862727 |
| 510k Number | K862727 |
| Device Name: | ZINETICS GASTROMETER (TM) |
| Classification | Electrode, Ph, Stomach |
| Applicant | ZINETICS MEDICAL TECHNOLOGY CORP. 2212 SOUTH WEST TEMPLE, #48 Salt Lake City, UT 84115 |
| Contact | Russell G Card |
| Correspondent | Russell G Card ZINETICS MEDICAL TECHNOLOGY CORP. 2212 SOUTH WEST TEMPLE, #48 Salt Lake City, UT 84115 |
| Product Code | FFT |
| CFR Regulation Number | 876.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-18 |
| Decision Date | 1986-11-19 |