FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LOSS OF RESISTANCE SYRINGE
K Number: K061737
·
Decision Dec 18, 2006
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
154
Applicant Total
1
Review Days
181
Basic Information
- Device Name
- LOSS OF RESISTANCE SYRINGE
- K Number
- K061737
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ROBERT BUSSE & CO., INC.
- Date Received
- June 20, 2006
- Decision Date
- December 18, 2006
- 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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