FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APT TRACHEA TUBES
K Number: K896181
·
Decision Jan 9, 1990
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
1
Review Days
76
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Basic Information
- Device Name
- APT TRACHEA TUBES
- K Number
- K896181
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Advanced Pulmonary Technologies, Inc.
- Date Received
- October 25, 1989
- Decision Date
- January 9, 1990
- 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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