Decision Date2007-10-19
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR 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 2007-10-19 under 510(k) number K072235. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR?
PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR is a medical device that received FDA 510(k) clearance on 2007-10-19. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K072235.
When did PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR receive FDA 510(k) clearance?
PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR received FDA 510(k) clearance on 2007-10-19, under 510(k) number K072235.
Who is the listed applicant for PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR?
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 PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR?
The FDA product code for PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR is DQA.
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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.