The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Esophageal Motility Apparatus.
| Device ID | K812103 |
| 510k Number | K812103 |
| Device Name: | ESOPHAGEAL MOTILITY APPARATUS |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | HONEYWELL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-24 |
| Decision Date | 1981-08-13 |