Sensis
FDA 510(k) clearance K150493 · decided 2015-06-30
Clearance details
- K-number
- K150493
- Device name
- Sensis
- Applicant
- Siemens Medi Cal Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-02-25
- Decision date
- 2015-06-30
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mavern, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Programmable Diagnostic Computer recall (Z-0775-2023) | Siemens Medical Solutions USA, Inc | 2023-01-01 |
| Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 66481 recall (Z-1243-2022) | Siemens Medical Solutions USA, Inc | 2022-06-06 |
| 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 110076 recall (Z-0499-2022) | Siemens Medical Solutions USA, Inc | 2022-01-14 |
| Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 664 recall (Z-1434-2021) | Siemens Medical Solutions USA, Inc | 2021-04-19 |
| Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic recall (Z-2921-2020) | Siemens Medical Solutions USA, Inc | 2020-08-28 |