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 |