The following data is part of a premarket notification filed by Medical Measurements, Inc. with the FDA for Gaeltec Mpr Series.
| Device ID | K921062 |
| 510k Number | K921062 |
| Device Name: | GAELTEC MPR SERIES |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | MEDICAL MEASUREMENTS, INC. 53 MAIN ST. Hackensack, NJ 07601 |
| Contact | William Sones |
| Correspondent | William Sones MEDICAL MEASUREMENTS, INC. 53 MAIN ST. Hackensack, NJ 07601 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-05 |
| Decision Date | 1992-07-30 |