The following data is part of a premarket notification filed by Medical Measurements, Inc. with the FDA for Mmi/gaeltec Catheter Tip Transduc.
| Device ID | K801756 |
| 510k Number | K801756 |
| Device Name: | MMI/GAELTEC CATHETER TIP TRANSDUC |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | MEDICAL MEASUREMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-28 |
| Decision Date | 1980-08-20 |