HFO — Recorder, Pressure, Intrauterine Class II
FDA product code HFO covers "Recorder, Pressure, Intrauterine", a Class II medical device regulated under 21 CFR 884.2700. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 4 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K973850 | alexander mfg | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007 | November 12, 1997 |
| K943989 | gabris surgical | LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT | September 12, 1994 |
| K791633 | life support | UC-2000 UTERINE CATHERIZATION SYSTEM | September 17, 1979 |
| K780487 | sonicaid | FETAL MONITORING SYSTEM | May 9, 1978 |