510(k) K830163
K830163 is an FDA 510(k) premarket notification submitted by Intl. Business Machines for the device "IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS". The FDA issued a decision of Substantially Equivalent on February 18, 1983. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Intl. Business Machines has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 1983
- Date Received
- January 18, 1983
- 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