FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRACHEAL TUBE FIXATION DEVICE
K Number: K843790
·
Decision Mar 11, 1985
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
46
Applicant Total
5
Review Days
165
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Basic Information
- Device Name
- TRACHEAL TUBE FIXATION DEVICE
- K Number
- K843790
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5770
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Laerdal California, Inc.
- Date Received
- September 27, 1984
- Decision Date
- March 11, 1985
- 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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Other Clearances by Laerdal California, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941578 | STATVAC PORTABLE SUCTION UNIT | May 18, 1994 | Substantially Equivalent |
| K922842 | STYLET AND TRACHEAL LIGHTWAND (STL) | Dec 18, 1992 | Substantially Equivalent |
| K862875 | E-VAC(TM) | Nov 3, 1986 | Substantially Equivalent |
| K832990 | STIFNICK IMMOBILIZING COLLAR | Nov 7, 1983 | Substantially Equivalent |