FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
EPISENSOR
K Number: K903224
·
Decision Dec 24, 1990
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
5
Review Days
154
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Basic Information
- Device Name
- EPISENSOR
- K Number
- K903224
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Palex Intl. SA
- Date Received
- July 23, 1990
- Decision Date
- December 24, 1990
- Product Code
- BSP
- 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 |
|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | FDA class 2 | Anesthesiology |
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