FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
EPIDURAL ANESTHESIA TRAY
K Number: K885278
·
Decision Mar 16, 1989
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
154
Applicant Total
6
Review Days
83
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Basic Information
- Device Name
- EPIDURAL ANESTHESIA TRAY
- K Number
- K885278
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Preferred Medical Products
- Date Received
- December 23, 1988
- Decision Date
- March 16, 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 Preferred Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K941153 | EPI-SPINAL ANESTHESIA TRAY | May 30, 1995 | Unknown |
| 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 |
| K885277 | SPINAL ANESTHESIA TRAY | Mar 6, 1989 | Substantially Equivalent |