FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ESOPHAGEAL STETHESCOPE
K Number: K800463
·
Decision Mar 10, 1980
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
12
Applicant Total
46
Review Days
10
Basic Information
- Device Name
- ESOPHAGEAL STETHESCOPE
- K Number
- K800463
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1910
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- MEDICAL COMPONENTS, INC.
- Date Received
- February 29, 1980
- Decision Date
- March 10, 1980
- Product Code
- BZW
- 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 |
|---|---|---|---|
| BZW | Stethoscope, Esophageal | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZW), ordered by most recent decision date.
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QUAZAR ESOPHAGEAL STETHOSCOPE
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ESOPHAGEAL STETHOSCOPE
FDA 510(k)
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