510(k) K964593
K964593 is an FDA 510(k) premarket notification submitted by S & W Medico Teknik A/S for the device "DIASCOPE TRAVELLER PLUS (4053)". The FDA issued a decision of Substantially Equivalent on June 30, 1997. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. S & W Medico Teknik A/S has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 1997
- Date Received
- November 15, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detector And Alarm, Arrhythmia
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type