Corometrics Model 5700 and 2264 Watertight Transducer
FDA 510(k) K982651 · Corometrics Medical Systems, Inc.
510(k) numberK982651
Submission
- Device name
- Corometrics Model 5700 and 2264 Watertight Transducer
- Applicant
- Corometrics Medical Systems, Inc.
Wallingford, CT, US - Received
- July 30, 1998
- Decision date
- December 11, 1998
- 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 |
|---|---|---|---|
| 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 |
| 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 |
More from Metrix Teknika, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K905000 | Aloka UST-964P-5 Endovaginal TransducerHEM · Traditional | 01/31/1991SE |
| K903623 | MODEL600 Uterine Activity MonitorHFM · Traditional | 11/07/1990SE |
| K891997 | Catalog #2270AAX, 2270DAX Beltless TocotransducerHFM · Traditional | 06/08/1989SE |
| K880900 | SSD-620 Linear/Convex Array Sector ScannerHEM · Traditional | 06/01/1988SE |
Questions and answers
When was Corometrics Model 5700 and 2264 Watertight Transducer cleared by the FDA?
Corometrics Model 5700 and 2264 Watertight Transducer (K982651) received a 510(k) decision of Substantially Equivalent on December 11, 1998, 134 days after the submission was received.
What is the product code of K982651?
The FDA product code is HEL – Monitor, Heart Rate, Fetal, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 884.2660.