510(k) K960168
- Device
- SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990
- Applicant
- SIEMENS ELEMA AB
- 510(k) number
- K960168
- Product code
- CBK
- Decision
- Se Subject To Tracking Reg (ST)
- Decision date
- 1996-10-25
- Date received
- 1996-01-16
- Regulation
- 868.5895
- Classification name
- Ventilator, Continuous, Facility Use
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEVEN CLARKE
- Address
- 49 Plain St. North Attleboro MA US 02760 02760
FDA Registration Numbers#
- 3004050971
- 8010939
- 1218704
- 3029227324
- 3017520736
- 3030446844
- 3012667060
- 9610531
- 1000604079
- 8030673
- 3011120183
- 3003477135
- 1000122786
- 2112020
- 3010817335
- 9680661
- 8030941
- 3011205710
- 3012772112
- 3010882708
- 3004428458
- 3001400310
- 1924066
- 3010317211
- 3016450067
- 3005783425
- 9617566
- 2011171
- 3011213495
- 8010042
- 3038259592
- 1218058
- 3008363989
- 3038562397
- 9611295
- 3021947238
- 3030733800
- 3042507287
- 9681384
- 3007603826
- 8021084
- 8020893
- 3008867836
- 3033526676
- 3001421318
- 3008496839
- 9610849
- 3008264065
- 3010952312
- 3029845
- 3006087789
- 1225492
- 3016723884
- 3003135857
- 1219324
- 3014766741
- 3014631252
- 3009077524
- 3033571078
- 3016618143
- 3006783791
- 3044156918
- 3029871637
- 3001104093
- 3010157426
- 3003862188
- 1066270
- 3007344957
- 3002797442
- 3009107628
- 3020283264
- 3023272766
- 3007549157
- 3006135941
- 3029922922
- 3031369651
- 1220908
- 3008102042
- 2085602
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CBK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253647 | Evita (V800); Evita (V600) | Draegerwerk AG & CO Kgaa | 2026-05-07 |
| K252663 | Inbentus Versatile | Iconic Solutions by Murcia, SL | 2026-04-14 |
| K251888 | VPAP Pediatric Face Mask | Hsiner Co., Ltd. | 2026-03-12 |
| K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | 2025-12-19 |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full | Fisher & Paykel Healthcare, Ltd. | 2025-09-10 |
| K243767 | SV600, SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-08-28 |
| K251133 | AVEA disposable expiratory filter/water trap (11790) | Telesair, Inc. | 2025-05-08 |
| K243394 | AF531 Oro-Nasal SE Face Mask | Respironics, Inc. | 2024-12-30 |
| K233486 | 731 Series Ventilator | ZOLL Medical Corporation | 2024-12-13 |
| K223120 | Ventoux VC2; Ventoux VC3 | Flight Medical Innovations , Ltd. | 2024-12-02 |
| K241135 | RESPOND(R) Ventilator | Corvent Medical, Inc. | 2024-11-13 |
| K241943 | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask | Sleepnet Corporation | 2024-08-28 |
| K232836 | Family of DIMAR DMAX NIV masks | Dimar S.P.A. | 2024-08-14 |
| K240807 | VM-2000 | Ventis Medical, Inc. | 2024-08-13 |
| K241520 | Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask | Sleepnet Corporation | 2024-06-27 |
Legacy Summary#
summary
FDA Review#
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