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HEO — Analyzer, Data, Obstetric Class III

FDA Device Classification

FDA product code HEO covers "Analyzer, Data, Obstetric", a Class III medical device regulated under 21 CFR 884.2050. Submissions are reviewed by the Obstetrics/Gynecology panel.

Classification Details

Product Code: HEO
Device Class: Class III
Regulation Number: 884.2050
Submission Type
Review Panel: OB
Medical Specialty: Obstetrics/Gynecology
Implant: No

Definition

Call for PMAs to be filed by 10/3/00 per 65 FR 41332 on 7/5/00