Spacelabs Medical Full Disclosure System, Model 91810
FDA 510(k) K063490 · Spacelabs Medical, Inc.
510(k) numberK063490
Submission
- Device name
- Spacelabs Medical Full Disclosure System, Model 91810
- Applicant
- Spacelabs Medical, Inc.
Issaquah, WA, US - Received
- November 17, 2006
- Decision date
- March 15, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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| K262006 | EnSite X EP SystemDQK · Special | Abbott Medical | 07/15/2026SE |
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| K253463 | ILR ECG Analyzer (IM007)DQK · Traditional | Implicity, Inc. | 07/02/2026SE |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01)DQK · Special | Imricor Medical Systems, Inc. | 06/30/2026SE |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO)DQK · Traditional | Micropace Pty, Ltd. | 06/12/2026SE |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…DQK · Special | Centerline Biomedical | 06/10/2026SE |
| K252859 | ZEUS Platform (FG0501US)DQK · Traditional | iRhythm Technologies, Inc. | 05/29/2026SE |
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| 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 |
| 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 |
| K050605 | Spacelabs Medical Multiparameter Module 91496DSI · Special | 05/03/2005SE |
Questions and answers
When was Spacelabs Medical Full Disclosure System, Model 91810 cleared by the FDA?
Spacelabs Medical Full Disclosure System, Model 91810 (K063490) received a 510(k) decision of Substantially Equivalent on March 15, 2007, 118 days after the submission was received.
What is the product code of K063490?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.