510(k) K062282

MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0 by Monebo Technologies, Inc. — Product Code DPS

K062282 is an FDA 510(k) premarket notification submitted by Monebo Technologies, Inc. for the device "MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0". The FDA issued a decision of Substantially Equivalent on Mar 22, 2007. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Monebo Technologies, Inc. has 3 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 22, 2007
Date Received
Aug 7, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type
510(k)

Source: FDA 510(k) database entry for K062282. Report a data issue: hello@regdatalab.com.