INTELLIVUE CLINICAL INFORMATION PORTFOLIO
FDA 510(k) clearance K100272 · decided 2010-04-14
Clearance details
- K-number
- K100272
- Device name
- INTELLIVUE CLINICAL INFORMATION PORTFOLIO
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2010-01-29
- Decision date
- 2010-04-14
- Days to decision
- 75 days
- Clearance type
- Special
- Product code
- DXJ
- Device class
- 2
- Regulation number
- 870.2450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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| Nexxis OR (K173381) | Barco N.V. | 2018-02-22 |
| Essence 55S Large Monitor System (K172969) | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | 2018-01-26 |
| Sorin Connect (K170460) | Sorin Group Deutschland GmbH | 2017-06-08 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips Medical: 865047 IntelliVue Clinical Information Portfolio Release D.03 865209 Inte recall (Z-3111-2011) | Philips Healthcare Inc. | 2011-08-31 |
| Philips IntelliVue Clinical Information Portfolio software as follows: 865047 IntelliVue C recall (Z-2175-2011) | Philips Healthcare Inc. | 2011-05-10 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HeartStart FRx Defibrillator and HeartStart SMART Pads II (P180028/S017) | Philips Medical Systems | 2025-09-05 |
| HeartStart FRx Defibrillator (861304) (P180028/S016) | Philips Medical Systems | 2025-06-09 |
| HeartStart FRx Defibrillator (P180028/S015) | Philips Medical Systems | 2025-05-09 |
| HeartStart FRx Defibrillator (861304) (P180028/S014) | Philips Medical Systems | 2024-02-21 |
| HeartStart FRx Defibrillator (P180028/S013) | Philips Medical Systems | 2023-04-03 |
| HeartStart FRx Defibrillator (P180028/S012) | Philips Medical Systems | 2022-03-20 |
| HeartStart FRx Defibrillator (861304) (P180028/S011) | Philips Medical Systems | 2021-11-15 |
| HeartStart FRx Defibrillator (861304) (P180028/S010) | Philips Medical Systems | 2021-09-24 |