The following data is part of a premarket notification filed by Par Medizintechnik Gmbh with the FDA for Tonoport V.
| Device ID | K012647 |
| 510k Number | K012647 |
| Device Name: | TONOPORT V |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | PAR MEDIZINTECHNIK GMBH EINEMSTRASSE 9 Berlin, DE D-10787 |
| Contact | Lothar Engel |
| Correspondent | Lothar Engel PAR MEDIZINTECHNIK GMBH EINEMSTRASSE 9 Berlin, DE D-10787 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-13 |
| Decision Date | 2001-11-09 |
| Summary: | summary |