FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
MEDCARE REGIONAL ANETHESIA KIT
K Number: K961075
·
Decision Sep 6, 1996
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
154
Applicant Total
8
Review Days
172
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Basic Information
- Device Name
- MEDCARE REGIONAL ANETHESIA KIT
- K Number
- K961075
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Medcare Medical Group, Inc.
- Date Received
- March 18, 1996
- Decision Date
- September 6, 1996
- 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 Medcare Medical Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973497 | HUBERLOC | Jan 13, 1998 | Substantially Equivalent |
| K970152 | BIOPSY TRAY | Mar 5, 1997 | Substantially Equivalent for Some Indications |
| K962849 | CATHETER INSERTION TRAY | Oct 7, 1996 | Substantially Equivalent |
| K962328 | SINGLE USE INSTRUMENT TRAY | Aug 9, 1996 | Substantially Equivalent |
| K962527 | GENERAL PURPOSE DENTAL TRAY | Aug 1, 1996 | Substantially Equivalent |
| K961880 | MEDCARE SUCTION CONNECTING TUBING | Jul 19, 1996 | Substantially Equivalent |
| K961167 | MEDCARE TRACHEOSTOMY CARE TRAY | Jul 2, 1996 | Unknown |