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U.S. Department of Health and Human Services

Product Classification
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Device analyzer, data, obstetric
Regulation Description Obstetric data analyzer.
Definition Call for PMAs to be filed by 10/3/00 per 65 FR 41332 on 7/5/00
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeHEO
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type PMA
Regulation Number 884.2050
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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