Product code HFO— Obstetrics/Gynecology
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007
- Classification name
- Recorder, Pressure, Intrauterine
- Device class
- Class 2
- Regulation
- 21 CFR 884.2700
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 4
- First cleared
- Most recent
Market context for product code HFO
FDA has cleared devices under product code HFO between 1978 and 1997, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1997
- 1994
- 1979
- 1978
Top applicants under product code HFO
Recent clearances under product code HFO
Data sourced from openFDA. This site is unofficial and independent of the FDA.