510(k) K240312
- Device
- Infinity CentralStation Wide
- Applicant
- Draeger Medical Systems, Inc.
- 510(k) number
- K240312
- Product code
- MHX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-01
- Date received
- 2024-02-02
- Regulation
- 870.1025
- Classification name
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Patrice Cocco
- Address
- 6 Tech Dr. Andover MA US 01810 01810
FDA Registration Numbers
- 3020115
- 2221819
- 3005877899
- 9710602
- 1218950
- 3032109181
- 1054713
- 3004196561
- 3009156722
- 3016701404
- 3006087789
- 3009077524
- 3010552191
- 3015997711
- 3018783526
- 3021736577
- 3010390468
- 3013557562
- 3005906887
- 3008716327
- 8030229
- 3012307300
- 3007481893
- 3004832480
- 3012238587
- 3009673645
- 3000162901
- 3017446092
- 3011120183
- 2080783
- 3010157426
- 3008058135
- 1066270
- 3009973336
- 3007734888
- 3008729547
- 3012421607
- 3013679558
- 1000484830
- 3007413079
- 3016618143
- 3004035727
- 3007603826
- 3014263632
- 3010611950
- 3014848734
- 3012528160
- 3014633893
- 3003832357
- 3015181391
- 3008363989
- 3007048291
- 3010536822
- 3007836437
- 3013896610
- 3003591740
- 3010703925
- 3015328411
- 2032233
- 3013314298
- 3001570235
- 3030516450
- 3004415095
- 9610816
- 3016931915
- 3003263092
- 3008642652
- 3000126629
- 3012972516
- 3030446844
- 3011353843
- 3003971136
- 9610105
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- 8022257
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- 3005783425
- 3012104670
- 3022123357
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- 1219324
- 3010698831
- 3013596024
- 3043479346
- 3023272766
- 9611500
- 1651104
- 3005521864
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- 3013501110
- 3004526608
- 8030978
- 1316463
- 3008483389
- 3013500228
- 3021219789
- 3016674095
- 3001104093
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- 3014541700
- 3009715978
- 3016852448
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- 3010882708
- 3007305624
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- 9611252
- 3031158
- 3008255748
- 3006147705
- 3009607734
- 9611031
- 1000122786
- 9681377
Source Documents
Other 510(k) Records For Product Code MHX
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250349 | Vista CMS | Shanghai Draeger Medical Instrument Co., Ltd. | 2026-04-24 |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-04-16 |
| K252250 | Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) | Shanghai Draeger Medical Instrument Co., Ltd. | 2026-04-10 |
| K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) | Philips Medizin Systeme Boeblingen GmbH | 2026-02-06 |
| K252589 | Corvair Monza | AliveCor, Inc. | 2026-01-09 |
| K250854 | Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro) | Shenzhen Comen Medical Instruments Co.,Ltd | 2025-12-17 |
| K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) | Philips Medizin Systeme Böblingen GmbH | 2025-11-10 |
| K251146 | IntelliVue Patient monitors MX400, MX450, MX500, MX550 | Philips Medizin Systeme Boeblingen GmbH | 2025-10-17 |
| K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) | Philips Medizin Systeme Böblingen GmbH | 2025-09-02 |
| K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | Edan Instruments, Inc. | 2025-07-29 |
| K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2025-07-09 |
| K250757 | Radius VSM and Accessories | Masimo Corporation | 2025-05-29 |
| K242962 | Telemetry Monitor 5500 Release 4.0 (867232) | Philips Medizin Systeme Böblingen GmbH | 2025-05-05 |
| K240320 | Patient Monitor (RespArray) | Edan Instruments, Inc. | 2024-06-28 |
| K231010 | Corvair | AliveCor, Inc. | 2024-06-07 |