FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STIFNICK IMMOBILIZING COLLAR
K Number: K832990
·
Decision Nov 7, 1983
Classifications
1
FEI Numbers
297
Registration Numbers
297
Same Product Code
26
Applicant Total
5
Review Days
67
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Basic Information
- Device Name
- STIFNICK IMMOBILIZING COLLAR
- K Number
- K832990
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3490
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Laerdal California, Inc.
- Date Received
- September 1, 1983
- Decision Date
- November 7, 1983
- Product Code
- IQK
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IQK | Orthosis, Cervical | FDA class 1 | Physical Medicine |
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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 |
| K843790 | TRACHEAL TUBE FIXATION DEVICE | Mar 11, 1985 | Substantially Equivalent |