510(k) K864505
K864505 is an FDA 510(k) premarket notification submitted by Spacelabs, Inc. for the device "SPACELABS ARRHYTHMIA NET (TM) LEVEL 2". The FDA issued a decision of Substantially Equivalent on November 24, 1986. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Spacelabs, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 1986
- Date Received
- November 14, 1986
- 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