Zoll Epcr Ios
FDA 510(k) K131919 · ZOLL Medical Corporation
510(k) numberK131919
Submission
- Device name
- Zoll Epcr Ios
- Applicant
- ZOLL Medical Corporation
Chelsmford, MA, US - Received
- June 26, 2013
- Decision date
- December 17, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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| 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 |
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| K180482 | ZOLL Propaq MMHX · Traditional | 11/30/2018SE |
| K172653 | Power InfuserFRN · Traditional | 07/18/2018SE |
| K162832 | 731 Series VentilatorsCBK · Traditional | 08/02/2017SE |
| K170533 | Model 330 Multifunction AspiratorBTA · Traditional | 04/18/2017SE |
| K142915 | ZOLL X SeriesMKJ · Traditional | 12/03/2014SE |
| K141774 | Zoll X SeriesMKJ · Traditional | 11/19/2014SE |
| K140502 | Zoll E Series AlsLDD · Traditional | 11/06/2014SE |
| K133484 | Zoll X SeriesMKJ · Traditional | 08/01/2014SE |
Questions and answers
When was Zoll Epcr Ios cleared by the FDA?
Zoll Epcr Ios (K131919) received a 510(k) decision of Substantially Equivalent on December 17, 2013, 174 days after the submission was received.
What is the product code of K131919?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.