FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRACH TIE, VENTILATOR TUBING HOLDER
K Number: K942016
·
Decision May 24, 1994
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
46
Applicant Total
3
Review Days
28
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Basic Information
- Device Name
- TRACH TIE, VENTILATOR TUBING HOLDER
- K Number
- K942016
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5770
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Garrett Medical Products
- Date Received
- April 26, 1994
- Decision Date
- May 24, 1994
- Product Code
- CBH
- 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 |
|---|---|---|---|
| CBH | Device, Fixation, Tracheal Tube | FDA class 1 | Anesthesiology |
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