FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
K Number: K954771
·
Decision May 9, 1996
Classifications
1
FEI Numbers
133
Registration Numbers
133
Same Product Code
31
Applicant Total
11
Review Days
205
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Basic Information
- Device Name
- TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
- K Number
- K954771
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5790
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Laerdal Medical Corp.
- Date Received
- October 17, 1995
- Decision Date
- May 9, 1996
- Product Code
- BSR
- 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 |
|---|---|---|---|
| BSR | Stylet, Tracheal Tube | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
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Other Clearances by Laerdal Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K001742 | RESUSCI INFLATE-A-SHIELD CPR BARRIER | Oct 6, 2000 | Substantially Equivalent |
| K962361 | TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND | Sep 5, 1996 | Substantially Equivalent |
| K954609 | HEARTSTART 911 | Jan 4, 1996 | Substantially Equivalent |
| K950698 | LSU 2000 PORTABLE SUCTION UNIT | May 9, 1995 | Substantially Equivalent |
| K933048 | LAERDAL(TM) POCKET MASK, MODIFICATION | Dec 2, 1993 | Substantially Equivalent |
| K896919 | HEARTSTART 3000 | May 3, 1990 | Substantially Equivalent |
| K880450 | RESUSCI PATIENT FACE SHIELD | Mar 4, 1988 | Substantially Equivalent |
| K861401 | LAERDAL POCKET MASK | May 21, 1986 | Substantially Equivalent |
| K840110 | LAERDAL SUCTION UNIT | Mar 12, 1984 | Substantially Equivalent |
| K822356 | MODULAIDE EMERG. CARDIAC LIFE SUPP. KT | Aug 20, 1982 | Substantially Equivalent |