HFOClass II
Recorder, Pressure, Intrauterine
21 CFR 884.2700 / Obstetrics/Gynecology
HFO is the FDA product code for Recorder, Pressure, Intrauterine, a class II device type, regulated under 21 CFR 884.2700. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- HFO
- Device name
- Recorder, Pressure, Intrauterine
- Regulation
- 21 CFR 884.2700
- Device class
- Class II
- Review panel
- Obstetrics/Gynecology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 4
- Ingested recalls
- 0
Clearances, product code HFO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 1 |
| 1994 | 1 |
| 1997 | 1 |
Applicants with the most clearances
Product code HFO| Applicant | Clearances |
|---|---|
| Alexander Mfg. Co. | 1 |
| Gabris Surgical Corp. | 1 |
| Life Support, Inc. | 1 |
| Sonicaid, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code HFO.
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