FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AIRWAY CONNECTOR WITH FLEX TUBE
K Number: K942392
·
Decision Aug 22, 1994
Classifications
1
FEI Numbers
167
Registration Numbers
167
Same Product Code
93
Applicant Total
43
Review Days
95
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Basic Information
- Device Name
- AIRWAY CONNECTOR WITH FLEX TUBE
- K Number
- K942392
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mallinckrodt Medical
- Date Received
- May 19, 1994
- Decision Date
- August 22, 1994
- Product Code
- BZA
- 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 |
|---|---|---|---|
| BZA | Connector, Airway (Extension) | FDA class 1 | Anesthesiology |
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