HFO
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Recorder, Pressure, Intrauterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2700
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007 (K973850) | Alexander Mfg. Co. | 1997-11-12 |
| LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT (K943989) | Gabris Surgical Corp. | 1994-09-12 |
| UC-2000 UTERINE CATHERIZATION SYSTEM (K791633) | Life Support, Inc. | 1979-09-17 |
| FETAL MONITORING SYSTEM (K780487) | Sonicaid, Inc. | 1978-05-09 |
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Every clearance here is in the API, with alerts when new ones post.