LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE
FDA 510(k) clearance K943732 · decided 1994-10-20
Clearance details
- K-number
- K943732
- Device name
- LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE
- Applicant
- Graphic Controls Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-02
- Decision date
- 1994-10-20
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- HGP
- Device class
- 2
- Regulation number
- 884.2675
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Buffalo, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) (K243291) | Neoventa Medical AB | 2025-01-17 |
| FETAL SPIRAL ELECTRODE, MODEL FSE07000 (K030691) | Clinical Innovations, Inc. | 2003-09-17 |
| SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 (K003458) | Clinical Innovations, Inc. | 2001-05-03 |
| 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 |
| MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE (K904745) | Graphic Controls Corp. | 1991-01-29 |
| 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 |
| SURGICRAFT COPELAND DISPOSABLE (K844608) | A.W. Showell (Surgicraft) , Ltd. | 1985-05-01 |
Recalls involving this device
No recalls on record reference this clearance.