510(k) K033410
K033410 is an FDA 510(k) premarket notification submitted by Remote Diagnostic Technologies , Ltd. for the device "TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002". The FDA issued a decision of Substantially Equivalent on March 5, 2004. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Remote Diagnostic Technologies , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 2004
- Date Received
- October 27, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Transmitters And Receivers, Electrocardiograph, Telephone
- Device Class
- Class II
- Regulation Number
- 870.2920
- Review Panel
- CV
- Submission Type