The following data is part of a premarket notification filed by Curbell Electronics Inc. with the FDA for Curbell Patient Monitoring Cables.
Device ID | K081762 |
510k Number | K081762 |
Device Name: | CURBELL PATIENT MONITORING CABLES |
Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
Applicant | CURBELL ELECTRONICS INC. 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
Contact | Kevin Walls |
Correspondent | Kevin Walls CURBELL ELECTRONICS INC. 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
Product Code | DSA |
CFR Regulation Number | 870.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-06-20 |
Decision Date | 2008-08-27 |
Summary: | summary |