510(k) K031760
K031760 is an FDA 510(k) premarket notification submitted by Datascope Corp. for the device "VIEWPOINT TELEMETRY SYSTEM". The FDA issued a decision of Substantially Equivalent on October 10, 2003. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Datascope Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 2003
- Date Received
- June 6, 2003
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type