The following data is part of a premarket notification filed by Jtl Medical Corp. with the FDA for Cardiopulmonary Bypass Level Sensing Monitor.
| Device ID | K910599 |
| 510k Number | K910599 |
| Device Name: | CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR |
| Classification | Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass |
| Applicant | JTL MEDICAL CORP. 3410-F LA SIERRA SUITE 208 Riverside, CA 92503 |
| Contact | James Lichte |
| Correspondent | James Lichte JTL MEDICAL CORP. 3410-F LA SIERRA SUITE 208 Riverside, CA 92503 |
| Product Code | DTW |
| CFR Regulation Number | 870.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-13 |
| Decision Date | 1993-05-20 |