The following data is part of a premarket notification filed by Datex Medical Instrumentation, Inc. with the FDA for Cardiocap Ii(tm).
| Device ID | K912530 |
| 510k Number | K912530 |
| Device Name: | CARDIOCAP II(TM) |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | DATEX MEDICAL INSTRUMENTATION, INC. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Vincent Rauscher |
| Correspondent | Vincent Rauscher DATEX MEDICAL INSTRUMENTATION, INC. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-07 |
| Decision Date | 1991-09-05 |