Essence 55SP Large Monitor System
FDA 510(k) K201162 · Shenyang Torch-Bigtide Digital Technology Co., Ltd.
510(k) numberK201162
Submission
- Device name
- Essence 55SP Large Monitor System
- Applicant
- Shenyang Torch-Bigtide Digital Technology Co., Ltd.
Shenyang, CN - Received
- April 30, 2020
- Decision date
- August 27, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
Other 510(k)s with product code DXJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212003 | ESSENZ Patient MonitorDXJ · Special | Livanova Deutschland, GmbH | 11/10/2021SE |
| K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X)DXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 09/30/2021SE |
| K173107 | Vios Central Station Monitor Software, Vios Central Server SoftwareDXJ · Traditional | Vios Medical, Inc. | 07/26/2018SE |
| K180534 | Philips IntelliVue GuardianSoftwareDXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 07/16/2018SE |
| K173381 | Nexxis ORDXJ · Special | Barco N.V. | 02/22/2018SE |
| K172969 | Essence 55S Large Monitor SystemDXJ · Traditional | Shenyang Torch-Bigtide Digital Technology Co.… | 01/26/2018SE |
| K170460 | Sorin ConnectDXJ · Special | Sorin Group Deutschland GmbH | 06/08/2017SE |
| K170537 | Nexxis OR, NexxisDXJ · Special | Barco N.V. | 04/21/2017SE |
| K161880 | NIVR58-T kitDXJ · Special | Barco N.V. | 03/14/2017SE |
| K161767 | Philips IntelliVue GuardianSoftwareDXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 01/27/2017SE |
More from Philips Medizin Systeme Boeblingen GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K172969 | Essence 55S Large Monitor SystemDXJ · Traditional | 01/26/2018SE |
Questions and answers
When was Essence 55SP Large Monitor System cleared by the FDA?
Essence 55SP Large Monitor System (K201162) received a 510(k) decision of Substantially Equivalent on August 27, 2020, 119 days after the submission was received.
What is the product code of K201162?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.