CARESCAPE R860

Ventilator, Continuous, Facility Use

Datex-Ohmeda, Inc.

The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Carescape R860.

Pre-market Notification Details

Device IDK210384
510k NumberK210384
Device Name:CARESCAPE R860
ClassificationVentilator, Continuous, Facility Use
Applicant Datex-Ohmeda, Inc. 3030 Ohmeda Drive, PO Box 7550 Madison,  WI  53707 -7550
ContactTrishia Mercier
CorrespondentMonica Morrison
Datex-Ohmeda, Inc. 3030 Ohmeda Drive, PO Box 7550 Madison,  WI  53707 -7550
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-09
Decision Date2021-11-04

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