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U.S. Department of Health and Human Services

Product Classification

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Device oximeter, reprocessed
Regulation Description Oximeter.
Definition same as DQA except reprocessed
Regulation Medical Specialty Cardiovascular
Review Panel Anesthesiology
Product CodeNLF
Premarket Review ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
Submission Type 510(k)
Regulation Number 870.2700
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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