The following data is part of a premarket notification filed by Vasocor, Inc. with the FDA for Vasocor Vascular Diagnostic Center (model 300).
| Device ID | K011625 |
| 510k Number | K011625 |
| Device Name: | VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300) |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | VASOCOR, INC. 499 A JESSEN LN. Charleston, NC 29492 |
| Contact | Walter M Rosebrough |
| Correspondent | Walter M Rosebrough VASOCOR, INC. 499 A JESSEN LN. Charleston, NC 29492 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-25 |
| Decision Date | 2002-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B2623000 | K011625 | 000 |