Decision Date2006-09-05
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
PULSE OXIMETER, MODEL PM-50 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 2006-09-05 under 510(k) number K061442. 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 PULSE OXIMETER, MODEL PM-50?
PULSE OXIMETER, MODEL PM-50 is a medical device that received FDA 510(k) clearance on 2006-09-05. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K061442.
When did PULSE OXIMETER, MODEL PM-50 receive FDA 510(k) clearance?
PULSE OXIMETER, MODEL PM-50 received FDA 510(k) clearance on 2006-09-05, under 510(k) number K061442.
Who is the listed applicant for PULSE OXIMETER, MODEL PM-50?
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 PULSE OXIMETER, MODEL PM-50?
The FDA product code for PULSE OXIMETER, MODEL PM-50 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.