US Sensor #CG-930P; Toco Sensor CG-940P
FDA 510(k) K003876 · Card Guard Scientific Survival , Ltd.
510(k) numberK003876
Submission
- Device name
- US Sensor #CG-930P; Toco Sensor CG-940P
- Applicant
- Card Guard Scientific Survival , Ltd.
Rehovot, IL - Received
- December 15, 2000
- Decision date
- July 9, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| 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 |
| K930714 | Sonicaid Model Team Fecg IupHEL · Traditional | Oxford Instruments, Plc. | 08/24/1995SE |
| K933816 | Sonicaid Model P110 Fetal Hear DetectorHEL · Traditional | Oxford Instruments, Plc. | 12/22/1994SE |
| K780035 | MinivisorHEL · Traditional | Metrix Teknika, Inc. | 03/06/1978SE |
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| K082521 | EASY2CHECK Blood Glucose and Blood Pressure Monitoring SystemNBW · Traditional | 01/16/2009SE |
| K081257 | CG-6108 ACT-3L Continuous ECG Monitor & Arrhythmia DetectorDSI · Special | 05/29/2008SE |
| K071995 | CG-6108 Continuous ECG Monitor and Arrhythmia DetectorDSI · Traditional | 12/18/2007SE |
| K061428 | PMP4 ApplicationMSX · Traditional | 10/16/2006SE |
| K061528 | Selfcheck GlucoCGA · Traditional | 09/22/2006SE |
Questions and answers
When was US Sensor #CG-930P; Toco Sensor CG-940P cleared by the FDA?
US Sensor #CG-930P; Toco Sensor CG-940P (K003876) received a 510(k) decision of Substantially Equivalent on July 9, 2001, 206 days after the submission was received.
What is the product code of K003876?
The FDA product code is HEL – Monitor, Heart Rate, Fetal, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 884.2660.