510(k) K992749

ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841 by Spacelabs Medical, Inc. — Product Code MSX

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