The following data is part of a premarket notification filed by Cnsystems Medizintechnik Gmbh with the FDA for Cnap Monitor.
| Device ID | K183521 |
| 510k Number | K183521 |
| Device Name: | CNAP Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CNSystems Medizintechnik GmbH Reininghausstrasse 13 Graz, AT 8020 |
| Contact | Bernd Wellisch |
| Correspondent | Bernd Wellisch CNSystems Medizintechnik GmbH Reininghausstrasse 13 Graz, AT 8020 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-19 |
| Decision Date | 2019-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09120073932242 | K183521 | 000 |
| 09120073932266 | K183521 | 000 |
| 09120073932990 | K183521 | 000 |
| 09120073933027 | K183521 | 000 |