SAM CRRT Unit, SAM Cassette CRRT
K-Number: K170790 · 2017-12-13
ApplicantSpectral Medical, Inc.
Decision Date2017-12-13
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
SAM CRRT Unit, SAM Cassette CRRT is a medical device manufactured by Spectral Medical, Inc.. It received FDA 510(k) clearance on 2017-12-13 under approval number K170790. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SAM CRRT Unit, SAM Cassette CRRT?
SAM CRRT Unit, SAM Cassette CRRT is a medical device that received FDA 510(k) clearance on 2017-12-13. It is manufactured by Spectral Medical, Inc.. The 510(k) number is K170790.
When was SAM CRRT Unit, SAM Cassette CRRT approved by the FDA?
SAM CRRT Unit, SAM Cassette CRRT received FDA 510(k) clearance on 2017-12-13, under approval number K170790.
What company makes SAM CRRT Unit, SAM Cassette CRRT?
SAM CRRT Unit, SAM Cassette CRRT is manufactured by Spectral Medical, Inc..
What is the FDA product code for SAM CRRT Unit, SAM Cassette CRRT?
The FDA product code for SAM CRRT Unit, SAM Cassette CRRT is KDI.
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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.