FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUPRA SCOPE
K Number: K801050
·
Decision May 14, 1980
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
2
Applicant Total
50
Review Days
9
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Basic Information
- Device Name
- SUPRA SCOPE
- K Number
- K801050
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1930
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Warner-Lambert Co.
- Date Received
- May 5, 1980
- Decision Date
- May 14, 1980
- Product Code
- BZS
- 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 |
|---|---|---|---|
| BZS | Stethoscope Head | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZS), ordered by most recent decision date.
DISPOSABLE STETHOSCOPE HEAD COVER
FDA 510(k)
FDA Class 1
·Anesthesiology
STETSKINS
FDA 510(k)
FDA Class 1
·Anesthesiology
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