HFO · Class II · 21 CFR 884.2700

FDA Product Code HFO: Recorder, Pressure, Intrauterine

Leading manufacturers include Sonicaid, Inc. and Alexander Mfg. Co..

4
Total
4
Cleared
33d
Avg days
1978
Since

FDA 510(k) Cleared Recorder, Pressure, Intrauterine Devices (Product Code HFO)

4 devices
1–4 of 4
Cleared Nov 12, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007
K973850
Alexander Mfg. Co.
Obstetrics & Gynecology · 35d
Cleared May 09, 1978
FETAL MONITORING SYSTEM
K780487
Sonicaid, Inc.
Obstetrics & Gynecology · 43d

About Product Code HFO - Regulatory Context