The following data is part of a premarket notification filed by Rocky Mountain Research, Inc. with the FDA for Levelsens - Flexible, Model 201110, Levelsens - Rigid, Model 201070.
| Device ID | K992857 |
| 510k Number | K992857 |
| Device Name: | LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 |
| Classification | Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass |
| Applicant | ROCKY MOUNTAIN RESEARCH, INC. 825 NORTH 300 WEST, SUITE 500 Salt Lake City, UT 84103 |
| Contact | Robert W Griffiths |
| Correspondent | Robert W Griffiths ROCKY MOUNTAIN RESEARCH, INC. 825 NORTH 300 WEST, SUITE 500 Salt Lake City, UT 84103 |
| Product Code | DTW |
| CFR Regulation Number | 870.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-25 |
| Decision Date | 1999-11-10 |