Decision Date2008-02-01
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
BS-200 CHEMISTRY ANALYZER, MODE BS-200 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2008-02-01 under 510(k) number K072018. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BS-200 CHEMISTRY ANALYZER, MODE BS-200?
BS-200 CHEMISTRY ANALYZER, MODE BS-200 is a medical device that received FDA 510(k) clearance on 2008-02-01. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K072018.
When did BS-200 CHEMISTRY ANALYZER, MODE BS-200 receive FDA 510(k) clearance?
BS-200 CHEMISTRY ANALYZER, MODE BS-200 received FDA 510(k) clearance on 2008-02-01, under 510(k) number K072018.
Who is the listed applicant for BS-200 CHEMISTRY ANALYZER, MODE BS-200?
The FDA 510(k) record lists Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BS-200 CHEMISTRY ANALYZER, MODE BS-200?
The FDA product code for BS-200 CHEMISTRY ANALYZER, MODE BS-200 is CFR.
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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.