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U.S. Department of Health and Human Services

Product Classification

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Device analyzer, ion, hydrogen-ion (ph), blood-phase, indwelling
Regulation Description Indwelling blood hydrogen ion concentration (pH) analyzer.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeCBZ
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.1170
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Guidance Documents
Third Party Review
Accredited Persons
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