UC-2000 Uterine Catherization System
FDA 510(k) K791633 · Life Support, Inc.
510(k) numberK791633
Submission
- Device name
- UC-2000 Uterine Catherization System
- Applicant
- Life Support, Inc.
Mchenry, IL, US - Received
- August 21, 1979
- Decision date
- September 17, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HFO – Recorder, Pressure, Intrauterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2700
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HFO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973850 | Alexander Manufacturing Co. Rechargeable Battery #M007HFO · Traditional | Alexander Mfg. Co. | 11/12/1997SE |
| K943989 | Laparoscopic/Endoscopic InstruementHFO · Traditional | Gabris Surgical Corp. | 09/12/1994SE |
| K780487 | Fetal Monitoring SystemHFO · Traditional | Sonicaid, Inc. | 05/09/1978SE |
More from Sonicaid, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K801984 | FE-3000 Fetal Electrode, Spiral SystemHGP · Traditional | 09/09/1980SE |
Questions and answers
When was UC-2000 Uterine Catherization System cleared by the FDA?
UC-2000 Uterine Catherization System (K791633) received a 510(k) decision of Substantially Equivalent on September 17, 1979, 27 days after the submission was received.
What is the product code of K791633?
The FDA product code is HFO – Recorder, Pressure, Intrauterine, a Class II (moderate risk) device regulated under 21 CFR 884.2700.