Ultraview Waveform Pager System, Model 91841
FDA 510(k) K992749 · Spacelabs Medical, Inc.
510(k) numberK992749
Submission
- Device name
- Ultraview Waveform Pager System, Model 91841
- Applicant
- Spacelabs Medical, Inc.
Redmond, WA, US - Received
- August 16, 1999
- Decision date
- January 14, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSX – System, Network And Communication, Physiological Monitors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| 510(k) | Device | Decision |
|---|---|---|
| K120616 | Spacelabs Healthcare Qube Compact Monitor (91390MHX · Special | 03/29/2012SE |
| K112962 | Spacelabs Healthcare Xprezzon Beside MONITOR(9913930)MHX · Special | 11/02/2011SE |
| K102422 | Spacelabs Medical Patient MonitorsMHX · Special | 12/07/2010SE |
| K093501 | Elance Vital Signs Monitor and Elance Central StationMHX · Special | 11/24/2009SE |
| K082045 | Modification to Mcare 300 Vital Signs Monitor, Model 91220MHX · Special | 08/01/2008SE |
| K063490 | Spacelabs Medical Full Disclosure System, Model 91810DQK · Traditional | 03/15/2007SE |
| K062095 | Mcare 300 Vital Signs Monitor, Model 91220MHX · Abbreviated | 09/29/2006SE |
| K062278 | Spacelabs Medical Clinical Event Interface, Model 91847MSX · Special | 09/19/2006SE |
| K060900 | Spacelabs Medical Bispectral Index (Bisx) Analysis Module 91482 and Accessories…OLW · Traditional | 06/23/2006SE |
| K053599 | Spacelabs Medical Multigas Analyzer Module 91518 and AccessoriesCBR · Special | 04/19/2006SE |
Questions and answers
When was Ultraview Waveform Pager System, Model 91841 cleared by the FDA?
Ultraview Waveform Pager System, Model 91841 (K992749) received a 510(k) decision of Substantially Equivalent on January 14, 2000, 151 days after the submission was received.
What is the product code of K992749?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.