The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Ultraview Waveform Pager System, Model 91841.
Device ID | K992749 |
510k Number | K992749 |
Device Name: | ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841 |
Classification | System, Network And Communication, Physiological Monitors |
Applicant | SPACELABS MEDICAL, INC. 15220 NORTH EAST 40TH ST. P.O. BOX 97013 Redmond, WA 98052 |
Contact | Nancy Gertlar |
Correspondent | Nancy Gertlar SPACELABS MEDICAL, INC. 15220 NORTH EAST 40TH ST. P.O. BOX 97013 Redmond, WA 98052 |
Product Code | MSX |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-16 |
Decision Date | 2000-01-14 |
Summary: | summary |