510(k) K992749
K992749 is an FDA 510(k) premarket notification submitted by Spacelabs Medical, Inc. for the device "ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841". The FDA issued a decision of Substantially Equivalent on January 14, 2000. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Spacelabs Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 2000
- Date Received
- August 16, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Network And Communication, Physiological Monitors
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type