The following data is part of a premarket notification filed by Cnsystem Medizintechnik Ag with the FDA for Non-invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500i, 500at.
| Device ID | K082599 |
| 510k Number | K082599 |
| Device Name: | NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CNSYSTEM MEDIZINTECHNIK AG REININGHAUSSTRASSE 13 Graz, AT 8020 |
| Contact | Sumper |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-09-08 |
| Decision Date | 2008-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09120073930101 | K082599 | 000 |
| 09120073930200 | K082599 | 000 |
| 09120073930194 | K082599 | 000 |
| 09120073930187 | K082599 | 000 |
| 09120073930170 | K082599 | 000 |
| 09120073930163 | K082599 | 000 |
| 09120073930156 | K082599 | 000 |
| 09120073930149 | K082599 | 000 |
| 09120073930132 | K082599 | 000 |
| 09120073930125 | K082599 | 000 |
| 09120073930118 | K082599 | 000 |
| 09120073930095 | K082599 | 000 |
| 09120073930064 | K082599 | 000 |
| 09120073930057 | K082599 | 000 |
| 09120073930040 | K082599 | 000 |
| 09120073930033 | K082599 | 000 |
| 09120073930026 | K082599 | 000 |
| 09120073930217 | K082599 | 000 |
| 09120073930224 | K082599 | 000 |
| 09120073930231 | K082599 | 000 |
| 09120073931368 | K082599 | 000 |
| 09120073931344 | K082599 | 000 |
| 09120073931139 | K082599 | 000 |
| 09120073931122 | K082599 | 000 |
| 09120073931115 | K082599 | 000 |
| 09120073930972 | K082599 | 000 |
| 09120073930958 | K082599 | 000 |
| 09120073930934 | K082599 | 000 |
| 09120073930767 | K082599 | 000 |
| 09120073930743 | K082599 | 000 |
| 09120073930668 | K082599 | 000 |
| 09120073930651 | K082599 | 000 |
| 09120073930385 | K082599 | 000 |
| 09120073930354 | K082599 | 000 |
| 09120073930262 | K082599 | 000 |
| 09120073930255 | K082599 | 000 |
| 09120073931528 | K082599 | 000 |