FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EPCOM EMS-310 INTRAPARTUM MONITOR
K Number: K831113
·
Decision Aug 12, 1983
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
213
Applicant Total
13
Review Days
129
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Basic Information
- Device Name
- EPCOM EMS-310 INTRAPARTUM MONITOR
- K Number
- K831113
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2740
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Epcom Medical Systems, Inc.
- Date Received
- April 5, 1983
- Decision Date
- August 12, 1983
- Product Code
- HGM
- 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 |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | FDA class 2 | Obstetrics/Gynecology |
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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 |
| K871079 | FETALFLEX FETAL ELECTRODE | Jul 13, 1987 | 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 |
| 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 |