FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW
K Number: K851480
·
Decision May 7, 1985
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
48
Review Days
22
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Basic Information
- Device Name
- VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW
- K Number
- K851480
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3270
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Vygon Corp.
- Date Received
- April 15, 1985
- Decision Date
- May 7, 1985
- Product Code
- LAE
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| LAE | High Pressure Liquid Chromatography, Codeine | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LAE), ordered by most recent decision date.
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