FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ESOPHAGEAL STETH. TEMP. SENSOR
K Number: K771411
·
Decision Sep 23, 1977
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
12
Applicant Total
4
Review Days
53
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Basic Information
- Device Name
- ESOPHAGEAL STETH. TEMP. SENSOR
- K Number
- K771411
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1910
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Labarge, Inc.
- Date Received
- August 1, 1977
- Decision Date
- September 23, 1977
- 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 |
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