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U.S. Department of Health and Human Services

Product Classification

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Device bed, pediatric open hospital
Regulation Description Pediatric medical crib.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFMS
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) Exempt
Regulation Number 880.5140
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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