Spacelabs Lifescreen PRO Analyzer
FDA 510(k) K201921 · Spacelabs Healthcare, Ltd.
510(k) numberK201921
Submission
- Device name
- Spacelabs Lifescreen PRO Analyzer
- Applicant
- Spacelabs Healthcare, Ltd.
Hertford, GB - Received
- July 10, 2020
- Decision date
- March 26, 2021
- 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
Other 510(k)s with product code DQK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262005 | Affera Integrated Mapping SystemDQK · Special | Medtronic, Inc. | 08/21/2026SE |
| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | Boston Scientific | 08/21/2026SE |
| K253576 | CorVista System® with PCWP Add-OnDQK · Traditional | Analytics For Life, Inc. | 07/26/2026SE |
| K262006 | EnSite X EP SystemDQK · Special | Abbott Medical | 07/15/2026SE |
| K252978 | ScioCardio ECG Analysis PlatformDQK · Traditional | Synergen Technology Labs, LLC | 07/09/2026SE |
| 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 |
More from iRhythm Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K212317 | Eclipse MINI Model 98900MWJ · Traditional | 11/07/2022SE |
| K211651 | Eclipse PROMWJ · Traditional | 11/22/2021SE |
| K152881 | Sentinel Cardiology Information Management SystemDQK · Traditional | 04/01/2016SE |
| K150329 | elance Vital Signs Monitor, Central Monitor SoftwareMHX · Traditional | 11/05/2015SE |
| K141113 | Spacelbs Model on Trak (90227) Ambulatory Bloody Pressure (Abp) Non-InvasiveDXN · Special | 09/26/2014SE |
| K141156 | Spacelabs Healthcare Telemetry ReceiverMHX · Traditional | 09/09/2014SE |
| K130207 | Spacelabs Healthcare CardioexpressDPS · Traditional | 07/23/2013SE |
| K122146 | Xhibit Central Station, Model 96102MHX · Traditional | 04/22/2013SE |
| K130112 | Capno Module, 92517CCK · Special | 03/21/2013SE |
| K121017 | Capnography Pad (92516)CCK · Special | 07/13/2012SE |
Questions and answers
When was Spacelabs Lifescreen PRO Analyzer cleared by the FDA?
Spacelabs Lifescreen PRO Analyzer (K201921) received a 510(k) decision of Substantially Equivalent on March 26, 2021, 259 days after the submission was received.
What is the product code of K201921?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.