Zoll Rescuenet Epcr Model Rescuenet Epcr
FDA 510(k) K103473 · ZOLL Medical Corporation
510(k) numberK103473
Submission
- Device name
- Zoll Rescuenet Epcr Model Rescuenet Epcr
- Applicant
- ZOLL Medical Corporation
Chelsmford, MA, US - Received
- November 24, 2010
- Decision date
- May 13, 2011
- 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
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| K173381 | Nexxis ORDXJ · Special | Barco N.V. | 02/22/2018SE |
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| K170460 | Sorin ConnectDXJ · Special | Sorin Group Deutschland GmbH | 06/08/2017SE |
| K170537 | Nexxis OR, NexxisDXJ · Special | Barco N.V. | 04/21/2017SE |
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| K142915 | ZOLL X SeriesMKJ · Traditional | 12/03/2014SE |
| K141774 | Zoll X SeriesMKJ · Traditional | 11/19/2014SE |
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Questions and answers
When was Zoll Rescuenet Epcr Model Rescuenet Epcr cleared by the FDA?
Zoll Rescuenet Epcr Model Rescuenet Epcr (K103473) received a 510(k) decision of Substantially Equivalent on May 13, 2011, 170 days after the submission was received.
What is the product code of K103473?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.