The following data is part of a premarket notification filed by Colin Corp. with the FDA for Vp-2000/1000.
| Device ID | K013434 |
| 510k Number | K013434 |
| Device Name: | VP-2000/1000 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | COLIN CORP. 2007-1 HAYASHI Komaki City, Aichi Pref., JP 485-8501 |
| Contact | Kenichi Sakurado |
| Correspondent | Kenichi Sakurado COLIN CORP. 2007-1 HAYASHI Komaki City, Aichi Pref., JP 485-8501 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-16 |
| Decision Date | 2002-07-09 |
| Summary: | summary |