510(k) K071911
- Device
- CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR
- Applicant
- INNOVISION A/S
- 510(k) number
- K071911
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-09-07
- Date received
- 2007-07-11
- Regulation
- 870.1425
- Classification name
- Computer, Diagnostic, Programmable
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD O WOOD
- Address
- 1025 Everett Rd. Suite 100 Lake Forest IL US 60045 60045
FDA Registration Numbers#
- 3013627970
- 9681377
- 3009831876
- 3008329188
- 3012528160
- 3013557562
- 3001592626
- 2032112
- 3016678045
- 3023272766
- 3009077524
- 3012268816
- 3000976525
- 2030404
- 2133772
- 9673241
- 3007029079
- 1219324
- 3007734888
- 3010288146
- 3014271754
- 3026523691
- 3000126629
- 3013300026
- 3017840980
- 3006087789
- 3037724692
- 3017060084
- 8030978
- 3010705768
- 1317188
- 3009715978
- 2024168
- 3000279201
- 1316463
- 3004594159
- 1527715
- 3017401510
- 3008203003
- 2135338
- 1064858
- 3004415095
- 2133810
- 2133641
- 3012619193
- 1018233
- 3013403214
- 3014848734
- 9610816
- 3004006614
- 2183744
- 1650907
- 3008012314
- 3011353843
- 2134265
- 3017233611
- 3002672225
- 2182208
- 3017638059
- 2126666
- 2184149
- 3016406615
- 3003971136
- 2438852
- 3016674095
- 1930027
- 9616760
- 2183715
- 3013943846
- 3030125003
- 3005210579
- 3007184699
- 3005334138
- 2183164
- 1054713
- 2031044
- 3003084417
- 1058031
- 3032916632
- 3009443693
Source Documents#
Other 510(k) Records For Product Code DQK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253576 | CorVista System® with PCWP Add-On | Analytics For Life, Inc. | 2026-07-26 |
| K262006 | EnSite™ X EP System | Abbott Medical | 2026-07-15 |
| K252978 | ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC | 2026-07-09 |
| K253463 | ILR ECG Analyzer (IM007) | Implicity, Inc. | 2026-07-02 |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems, Inc. | 2026-06-30 |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty, Ltd. | 2026-06-12 |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035) | Centerline Biomedical | 2026-06-10 |
| K252859 | ZEUS Platform (FG0501US) | iRhythm Technologies, Inc. | 2026-05-29 |
| K260212 | EnSite™ X EP System | ABBOTT MEDICAL | 2026-04-20 |
| K253861 | ACORYS MAPPING SYSTEM | Corify Care S.L | 2026-04-13 |
| K253473 | Synchrony | Stereotaxis, Inc. | 2026-04-01 |
| K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026-02-24 |
| K252972 | CARTO™ 3 EP Navigation System V8.4 | Biosense Webster, Inc. | 2026-02-20 |
| K254089 | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) | Centerline Biomedical, Inc. | 2026-02-17 |
| K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | 2026-02-09 |
Legacy Summary#
summary
FDA Review#
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