FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
E-SP COMBINED EPI SPINAL MINISET
K Number: K925014
·
Decision Apr 19, 1993
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
154
Applicant Total
5
Review Days
199
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Basic Information
- Device Name
- E-SP COMBINED EPI SPINAL MINISET
- K Number
- K925014
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Neuro Technology
- Date Received
- October 2, 1992
- Decision Date
- April 19, 1993
- 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 Neuro Technology
| K Number | Device Name | ||
|---|---|---|---|
| K901810 | MICRO-SP LUMBAR PUNCTURE (SPINAL) NEEDLE | May 30, 1991 | Substantially Equivalent |
| K901811 | ADD'L DATA E-SP MULTIPURPOSE EPIDURAL SPINALNEEDLE | May 28, 1991 | Substantially Equivalent |
| K822139 | STIMPEN | Sep 13, 1982 | Substantially Equivalent |
| K822138 | NEUROSTIM II | Jul 30, 1982 | Substantially Equivalent |