HFO — Recorder, Pressure, Intrauterine Class II

FDA Device Classification

Classification Details

Product Code
HFO
Device Class
Class II
Regulation Number
884.2700
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K973850alexander mfgALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007November 12, 1997
K943989gabris surgicalLAPAROSCOPIC/ENDOSCOPIC INSTRUEMENTSeptember 12, 1994
K791633life supportUC-2000 UTERINE CATHERIZATION SYSTEMSeptember 17, 1979
K780487sonicaidFETAL MONITORING SYSTEMMay 9, 1978