The following data is part of a premarket notification filed by Ramsey Medical, Inc. with the FDA for Statmap, Model 7200.
Device ID | K072109 |
510k Number | K072109 |
Device Name: | STATMAP, MODEL 7200 |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | RAMSEY MEDICAL, INC. 4920 WEST CYPRESS STREET Tampa, FL 33607 -3837 |
Contact | Darryl Parmet |
Correspondent | Darryl Parmet RAMSEY MEDICAL, INC. 4920 WEST CYPRESS STREET Tampa, FL 33607 -3837 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-01 |
Decision Date | 2008-07-31 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860498002616 | K072109 | 000 |
00860498002609 | K072109 | 000 |