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U.S. Department of Health and Human Services

Product Classification

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Device incubator, neonatal
Regulation Description Neonatal incubator.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFMZ
Premarket Review Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors (OHT3)
Drug Delivery and General Hospital Devices and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.5400
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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