HFO · Recorder, Pressure, Intrauterine
Obstetrics/Gynecology · 21 CFR 884.2700 · Class 2
Overview
| Product Code | HFO |
|---|---|
| Device Name | Recorder, Pressure, Intrauterine |
| Regulation | 21 CFR 884.2700 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
An intrauterine pressure monitor is a device designed to detect and measure intrauterine and amniotic fluid pressure with a catheter placed transcervically into the uterine cavity. The device is used to monitor intensity, duration, and frequency of uterine contractions during labor. This generic type of device may include the following accessories: signal analysis and display equipment, patient and equipment supports, and component parts.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K973850 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007 | Alexander Mfg. Co. | Nov 12, 1997 | SESE |
| K943989 | LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT | Gabris Surgical Corp. | Sep 12, 1994 | SESE |
| K791633 | UC-2000 UTERINE CATHERIZATION SYSTEM | Life Support, Inc. | Sep 17, 1979 | SESE |
| K780487 | FETAL MONITORING SYSTEM | Sonicaid, Inc. | May 9, 1978 | SESE |
Top Applicants
- Alexander Mfg. Co. — 1 clearance
- Gabris Surgical Corp. — 1 clearance
- Life Support, Inc. — 1 clearance
- Sonicaid, Inc. — 1 clearance
