Philips IntelliVue GuardianSoftware
FDA 510(k) clearance K180534 · decided 2018-07-16
Clearance details
- K-number
- K180534
- Device name
- Philips IntelliVue GuardianSoftware
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Decision
- Substantially Equivalent
- Date received
- 2018-02-28
- Decision date
- 2018-07-16
- Days to decision
- 138 days
- Clearance type
- Traditional
- Product code
- DXJ
- Device class
- 2
- Regulation number
- 870.2450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boeblingen, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ESSENZ Patient Monitor (K212003) | Livanova Deutschland, GmbH | 2021-11-10 |
| Philips IntelliVue GuardianSoftware (Rev. E.0X) (K212208) | Philips Medizin Systeme Boeblingen GmbH | 2021-09-30 |
| Essence 55SP Large Monitor System (K201162) | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | 2020-08-27 |
| Vios Central Station Monitor Software, Vios Central Server Software (K173107) | Vios Medical, Inc. | 2018-07-26 |
| 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 |
| Nexxis OR, Nexxis (K170537) | Barco N.V. | 2017-04-21 |
| NIVR58-T kit (K161880) | Barco N.V. | 2017-03-14 |
| Philips IntelliVue GuardianSoftware (K161767) | Philips Medizin Systeme Boeblingen GmbH | 2017-01-27 |
| CARESCAPE Central Station V2 (K162012) | GE Healthcare | 2016-09-15 |
| Philips CS770 IntelliSpace Critical Care and Anesthesia (K151366) | Philips Medical Systems | 2015-10-30 |
Recalls involving this device
No recalls on record reference this clearance.