510(k) K922528
- Device
- CMS SYSTEM
- Applicant
- MICROMEDICAL INDUSTRIES, LTD.
- 510(k) number
- K922528
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-05-12
- Date received
- 1992-05-28
- Regulation
- 870.1425
- Classification name
- Computer, Diagnostic, Programmable
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- HARRY PLATT
- Address
- 255 Revere Dr. Suite 101 Northbrook IL US 60062 60062
FDA Registration Numbers#
- 3004016520
- 3021016555
- 3010155648
- 3024821700
- 9615817
- 3003144120
- 9611295
- 2024168
- 3026523691
- 3016701404
- 3014579161
- 3000976525
- 3007603855
- 2135338
- 1320894
- 2030404
- 3010288146
- 3045323923
- 9673241
- 3012359877
- 3016674095
- 3045498928
- 3008483389
- 3007603826
- 3032916632
- 3004091615
- 1650907
- 3022435840
- 2438852
- 3010089768
- 2134265
- 3033300766
- 3043479346
- 3004977335
- 3008203003
- 2183164
- 9610816
- 3008452825
- 3002672225
- 3009831876
- 3017845286
- 3009443693
- 3018940143
- 9610105
- 3033959233
- 3007029079
- 2648045
- 1930027
- 3004006614
- 3017638059
- 3033558564
- 3013500228
- 3021769057
- 3011353843
- 3014848734
- 3012027770
- 1316463
- 3008729547
- 3003617581
- 2246552
- 3017233611
- 3013596024
- 2184149
- 3008717264
- 8030978
- 3003768277
- 2126666
- 3009254201
- 1218950
- 3018783526
- 3006087789
- 3030721635
- 3009715978
- 2183715
- 1000165971
- 3010157426
- 2133641
- 3023272766
- 2952596
- 3012154226
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DQK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253692 | AVVIGO™+ Multi-Modality Guidance System | Boston Scientific | 2026-08-21 |
| K262005 | Affera Integrated Mapping System | Medtronic, Inc. | 2026-08-21 |
| 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 |
Legacy Summary#
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FDA Review#
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