FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM
K Number: K012387
·
Decision Apr 23, 2002
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
25
Applicant Total
2
Review Days
270
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Basic Information
- Device Name
- STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM
- K Number
- K012387
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1900
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stethographics, Inc.
- Date Received
- July 27, 2001
- Decision Date
- April 23, 2002
- Product Code
- BZM
- 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 |
|---|---|---|---|
| BZM | Calculator, Pulmonary Function Interpretor (Diagnostic) | FDA class 2 | Anesthesiology |
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Other Clearances by Stethographics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K052283 | HEART STG SYSTEM AND SOFTWARE | Dec 23, 2005 | Substantially Equivalent |