The following data is part of a premarket notification filed by Inovise Medical, Inc. with the FDA for Liberty System.
Device ID | K043074 |
510k Number | K043074 |
Device Name: | LIBERTY SYSTEM |
Classification | Electrocardiograph |
Applicant | INOVISE MEDICAL, INC. 10565 SW NIMBUS AVE. SUITE 100 Portland, OR 97223 |
Contact | Steve Hesler |
Correspondent | Steve Hesler INOVISE MEDICAL, INC. 10565 SW NIMBUS AVE. SUITE 100 Portland, OR 97223 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-11-08 |
Decision Date | 2005-02-22 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LIBERTY SYSTEM 73526688 1393026 Dead/Cancelled |
SYNECTICS MEDICAL INC. 1985-03-13 |