FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
EPI-SPINAL ANESTHESIA TRAY
K Number: K941153
·
Decision May 30, 1995
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
154
Applicant Total
6
Review Days
445
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Basic Information
- Device Name
- EPI-SPINAL ANESTHESIA TRAY
- K Number
- K941153
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Preferred Medical Products
- Date Received
- March 11, 1994
- Decision Date
- May 30, 1995
- 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 Preferred Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K924699 | PMP MUSCLE STIMULATOR | Apr 30, 1993 | Substantially Equivalent |
| K920808 | OB/GYN DRAPE | Feb 19, 1993 | Substantially Equivalent |
| K904440 | LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS | Jun 7, 1991 | Substantially Equivalent |
| K885278 | EPIDURAL ANESTHESIA TRAY | Mar 16, 1989 | Substantially Equivalent |
| K885277 | SPINAL ANESTHESIA TRAY | Mar 6, 1989 | Substantially Equivalent |