510(k) K902254
K902254 is an FDA 510(k) premarket notification submitted by Medical Data Electronics for the device "ESCORT MODEL 400T TELEMETRY ECG MONITOR". The FDA issued a decision of Substantially Equivalent on July 27, 1990. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Medical Data Electronics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1990
- Date Received
- May 21, 1990
- 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