Sonicaid Model Team Fecg Iup
FDA 510(k) K930714 · Oxford Instruments, Plc.
510(k) numberK930714
Submission
- Device name
- Sonicaid Model Team Fecg Iup
- Applicant
- Oxford Instruments, Plc.
Clearwater, FL, US - Received
- February 11, 1993
- Decision date
- August 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HEL – Monitor, Heart Rate, Fetal, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2660
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HEL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K003876 | US Sensor #CG-930P; Toco Sensor CG-940PHEL · Traditional | Card Guard Scientific Survival , Ltd. | 07/09/2001SE |
| K010920 | Transducers for Fetal Ultrasonic and Tokodynamometer MonitoringHEL · Traditional | Medical Cables, Inc. | 06/22/2001SE |
| K982651 | Corometrics Model 5700 and 2264 Watertight TransducerHEL · Traditional | Corometrics Medical Systems, Inc. | 12/11/1998SE |
| K971240 | Alexander Manufacturing Co. Rechargeable Battery Part Number M006HEL · Traditional | Alexander Mfg. Co. | 06/06/1997SE |
| K933816 | Sonicaid Model P110 Fetal Hear DetectorHEL · Traditional | Oxford Instruments, Plc. | 12/22/1994SE |
| K780035 | MinivisorHEL · Traditional | Metrix Teknika, Inc. | 03/06/1978SE |
More from Metrix Teknika, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002150 | Sonicaid FM820, Sonicaid FM830HGM · Traditional | 03/09/2001SE |
| K002544 | Medilog Excel 2 - Holter Management SystemDQK · Special | 09/13/2000SE |
| K981405 | Synergy LTGWF · Traditional | 07/16/1998SE |
| K961642 | Medilog MR95GWQ · Traditional | 01/17/1997SE |
| K961636 | Medilog VisionOLZ · Traditional | 01/17/1997SE |
| K933816 | Sonicaid Model P110 Fetal Hear DetectorHEL · Traditional | 12/22/1994SE |
Questions and answers
When was Sonicaid Model Team Fecg Iup cleared by the FDA?
Sonicaid Model Team Fecg Iup (K930714) received a 510(k) decision of Substantially Equivalent on August 24, 1995, 924 days after the submission was received.
What is the product code of K930714?
The FDA product code is HEL – Monitor, Heart Rate, Fetal, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 884.2660.