The following data is part of a premarket notification filed by Finapres Medical Systems Bv with the FDA for Finometer Model-2 With Accessories.
| Device ID | K063111 |
| 510k Number | K063111 |
| Device Name: | FINOMETER MODEL-2 WITH ACCESSORIES |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | FINAPRES MEDICAL SYSTEMS BV PAASHEUVELWEG 34A Amsterdam Zo, NL Nl-1105 |
| Contact | Gerad J Langewouters |
| Correspondent | Patricia L Murphy KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-10-11 |
| Decision Date | 2007-02-01 |