FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FETALFLEX FETAL ELECTRODE
K Number: K871079
·
Decision Jul 13, 1987
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
16
Applicant Total
13
Review Days
117
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Basic Information
- Device Name
- FETALFLEX FETAL ELECTRODE
- K Number
- K871079
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2675
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Epcom Medical Systems, Inc.
- Date Received
- March 18, 1987
- Decision Date
- July 13, 1987
- Product Code
- HGP
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HGP | Electrode, Circular (Spiral), Scalp And Applicator | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HGP), ordered by most recent decision date.
Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)
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FETAL SPIRAL ELECTRODE, MODEL FSE07000
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SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
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LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE
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CR SPIRAL ELECTRODE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FETAL SCALP SPIRAL ELECTRODE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Epcom Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K910518 | GLOVE-N-GEL AMNIOTOMY KIT | May 9, 1991 | Unknown |
| K905812 | INTRAUTERINE CATHETER SET | Jan 31, 1991 | Substantially Equivalent |
| K881414 | CERVICATH | Jun 14, 1988 | Substantially Equivalent |
| K844338 | 1URO-LOG HOME DIAGNOSTIC PACK | Feb 25, 1985 | Substantially Equivalent |
| K844503 | UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK | Jan 2, 1985 | Substantially Equivalent |
| K841805 | OBSTETRICAL DOPPLER | Jun 19, 1984 | Substantially Equivalent |
| K831115 | EPCOM EMS-320 REMOTE MONITORSCOPE | Aug 12, 1983 | Substantially Equivalent |
| K831113 | EPCOM EMS-310 INTRAPARTUM MONITOR | Aug 12, 1983 | Substantially Equivalent |
| K831114 | EPCOM EMS-330 FREEDOM I TELEDOP OBSTET | Aug 12, 1983 | Substantially Equivalent |
| K831112 | EPCOM VCU-1 VACUUM SYSTEM & CURETTE | Jun 30, 1983 | Substantially Equivalent |