The following data is part of a premarket notification filed by Rocky Mountain Research, Inc. with the FDA for Els Automatic Tubing Clamp System.
| Device ID | K961598 |
| 510k Number | K961598 |
| Device Name: | ELS AUTOMATIC TUBING CLAMP SYSTEM |
| Classification | Detector, Bubble, Cardiopulmonary Bypass |
| Applicant | ROCKY MOUNTAIN RESEARCH, INC. 2715 EAST 3300 SOUTH Salt Lake City, UT 84109 |
| Contact | Robert W Griffiths |
| Correspondent | Robert W Griffiths ROCKY MOUNTAIN RESEARCH, INC. 2715 EAST 3300 SOUTH Salt Lake City, UT 84109 |
| Product Code | KRL |
| CFR Regulation Number | 870.4205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-09 |
| Decision Date | 1996-10-29 |