FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
MEDIZIV EPIDURAL SYSTEMS
K Number: K894725
·
Decision Oct 13, 1989
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
154
Applicant Total
2
Review Days
80
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Basic Information
- Device Name
- MEDIZIV EPIDURAL SYSTEMS
- K Number
- K894725
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Mediziv Medical Devices, Ltd.
- Date Received
- July 25, 1989
- Decision Date
- October 13, 1989
- Product Code
- CAZ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAZ | Anesthesia Conduction Kit | FDA class 2 | Anesthesiology |
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Other Clearances by Mediziv Medical Devices, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K884491 | MEDIZIV CENTRAL VEIN CATHETER | Jun 5, 1989 | Substantially Equivalent |