The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Capiox Level Alarm.
| Device ID | K915337 |
| 510k Number | K915337 |
| Device Name: | CAPIOX LEVEL ALARM |
| Classification | Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass |
| Applicant | TERUMO MEDICAL CORP. P.O. BOX 605 Elkton, MD 21912 |
| Contact | Sandi Hartka |
| Correspondent | Sandi Hartka TERUMO MEDICAL CORP. P.O. BOX 605 Elkton, MD 21912 |
| Product Code | DTW |
| CFR Regulation Number | 870.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-26 |
| Decision Date | 1992-02-21 |