510(k) K042849
K042849 is an FDA 510(k) premarket notification submitted by Cardiobiomedical Corporation for the device "CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)". The FDA issued a decision of Substantially Equivalent on Jan 13, 2005. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 13, 2005
- Date Received
- Oct 15, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type
- 510(k)