FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
1URO-LOG HOME DIAGNOSTIC PACK
K Number: K844338
·
Decision Feb 25, 1985
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
16
Applicant Total
13
Review Days
109
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Basic Information
- Device Name
- 1URO-LOG HOME DIAGNOSTIC PACK
- K Number
- K844338
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1800
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Epcom Medical Systems, Inc.
- Date Received
- November 8, 1984
- Decision Date
- February 25, 1985
- Product Code
- FFG
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FFG | Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FFG), ordered by most recent decision date.
PEAK FLOW RATE METER
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SURGITEK (R) UROFLOW SYSTEM
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ERIS URO-DIAGNOSTIC SYSTEM
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FDA Class 2
·Gastroenterology, Urology
URINARY DRAINAGE CONTAINER 2012-WITH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
URINARY DRAINAGE CONTAINER 2013 WITH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCUMETER ELECTRONIC URINEMETER SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| 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 |