510(k) K010920
- Device
- TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
- Applicant
- MEDICAL CABLES, INC.
- 510(k) number
- K010920
- Product code
- HEL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-06-22
- Date received
- 2001-03-27
- Regulation
- 884.2660
- Classification name
- Monitor, Heart Rate, Fetal, Ultrasonic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT HILMAN
- Address
- 1340 Logan Ave. Costa Mesa CA US 92626 92626
FDA Registration Numbers#
- 1450908
- 3007734888
- 9617277
Source Documents#
Other 510(k) Records For Product Code HEL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K003876 | US SENSOR #CG-930P; TOCO SENSOR CG-940P | Card Guard Scientific Survival , Ltd. | 2001-07-09 |
| K982651 | COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER | Corometrics Medical Systems, Inc. | 1998-12-11 |
| K971240 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006 | Alexander Mfg. Co. | 1997-06-06 |
| K930714 | SONICAID MODEL TEAM FECG IUP | Oxford Instruments, Plc. | 1995-08-24 |
| K933816 | SONICAID MODEL P110 FETAL HEAR DETECTOR | Oxford Instruments, Plc. | 1994-12-22 |
| K780035 | MINIVISOR | Metrix Teknika, Inc. | 1978-03-06 |
Legacy Summary#
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FDA Review#
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