CARESCAPE R860
K-Number: K210384 · 2021-11-04
ApplicantDatex-Ohmeda, Inc.
Decision Date2021-11-04
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
CARESCAPE R860 is a medical device manufactured by Datex-Ohmeda, Inc.. It received FDA 510(k) clearance on 2021-11-04 under approval number K210384. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CARESCAPE R860?
CARESCAPE R860 is a medical device that received FDA 510(k) clearance on 2021-11-04. It is manufactured by Datex-Ohmeda, Inc.. The 510(k) number is K210384.
When was CARESCAPE R860 approved by the FDA?
CARESCAPE R860 received FDA 510(k) clearance on 2021-11-04, under approval number K210384.
What company makes CARESCAPE R860?
CARESCAPE R860 is manufactured by Datex-Ohmeda, Inc..
What is the FDA product code for CARESCAPE R860?
The FDA product code for CARESCAPE R860 is CBK.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.