COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE
FDA 510(k) clearance K792669 · decided 1980-02-11
Clearance details
- K-number
- K792669
- Device name
- COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE
- Applicant
- Ge Medical Systems Information Technologies
- Decision
- Substantially Equivalent
- Date received
- 1979-12-27
- Decision date
- 1980-02-11
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- HGP
- Device class
- 2
- Regulation number
- 884.2675
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE (K943732) | Graphic Controls Corp. | 1994-10-20 |
| CR SPIRAL ELECTRODE (K910815) | Neward Enterprises, Inc. | 1991-12-10 |
| FETAL SCALP SPIRAL ELECTRODE (K911657) | Advanced Medical Systems, Inc. | 1991-07-11 |
| COMBO FETAL SCALP ELECTRODE/LEGPLATE (K905830) | Utah Medical Products, Inc. | 1991-03-29 |
| FETAL MONITORING SPIRAL ELECTRODE (K905130) | Graphic Controls Corp. | 1991-01-29 |
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| REDYPLATE DISPOSABLE LEG PLATE (K901152) | Medical Accessories, Inc. | 1990-04-04 |
| FETAL SCALP ELECTRODE (K872057) | Medical Accessories, Inc. | 1987-11-16 |
| FETALFLEX FETAL ELECTRODE (K871079) | Epcom Medical Systems, Inc. | 1987-07-13 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spi recall (Z-0330-2013) | Vital Signs Devices, a GE Healthcare Company | 2012-11-16 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING (P000016/S002) | Ge Medical Systems Information Technologies | 2003-10-15 |
| COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY (P000016/S001) | Ge Medical Systems Information Technologies | 2001-11-09 |
| COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR (P000016) | Ge Medical Systems Information Technologies | 2001-02-09 |
| MODEL 515 NEONATAL MONIOTR (P840037/S001) | Ge Medical Systems Information Technologies | 1986-11-19 |