FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WELL LEAD ENDOTRACHEAL TUBE
K Number: K042683
·
Decision Feb 18, 2005
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
4
Review Days
142
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Basic Information
- Device Name
- WELL LEAD ENDOTRACHEAL TUBE
- K Number
- K042683
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Well Lead Medical Instruments
- Date Received
- September 29, 2004
- Decision Date
- February 18, 2005
- Product Code
- BTR
- 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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