510(k) K944362
K944362 is an FDA 510(k) premarket notification submitted by Instromedix, Inc. for the device "HEARTCARD CARDIAC EVENT MONITOR". The FDA issued a decision of Substantially Equivalent on September 7, 1995. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Instromedix, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 1995
- Date Received
- September 7, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transmitters And Receivers, Electrocardiograph, Telephone
- Device Class
- Class II
- Regulation Number
- 870.2920
- Review Panel
- CV
- Submission Type