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 |