The following data is part of a premarket notification filed by Konigsberg Instruments, Inc. with the FDA for Esophageal Motility Probe.
| Device ID | K811083 |
| 510k Number | K811083 |
| Device Name: | ESOPHAGEAL MOTILITY PROBE |
| Classification | Electrode, Ph, Stomach |
| Applicant | KONIGSBERG INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FFT |
| CFR Regulation Number | 876.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-21 |
| Decision Date | 1981-08-13 |