Decision Date2008-01-08
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
PM-60 PULSE OXIMETER 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 2008-01-08 under 510(k) number K072581. 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-60 PULSE OXIMETER?
PM-60 PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 2008-01-08. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K072581.
When did PM-60 PULSE OXIMETER receive FDA 510(k) clearance?
PM-60 PULSE OXIMETER received FDA 510(k) clearance on 2008-01-08, under 510(k) number K072581.
Who is the listed applicant for PM-60 PULSE OXIMETER?
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-60 PULSE OXIMETER?
The FDA product code for PM-60 PULSE OXIMETER 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.