The following data is part of a premarket notification filed by Medical Measurements, Inc. with the FDA for Mmi/gaeltec Catheter Tip Pressure.
| Device ID | K801755 |
| 510k Number | K801755 |
| Device Name: | MMI/GAELTEC CATHETER TIP PRESSURE |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | MEDICAL MEASUREMENTS, INC. NJ |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-28 |
| Decision Date | 1980-08-13 |