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U.S. Department of Health and Human Services

Product Classification

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Device manometer, spinal-fluid
Regulation Description Spinal fluid manometer.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFMJ
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.2500
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
Third Party Review
Accredited Persons
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