FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE
K Number: K991756
·
Decision Dec 10, 1999
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
153
Applicant Total
10
Review Days
200
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Basic Information
- Device Name
- 3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE
- K Number
- K991756
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Research Associates, Inc.
- Date Received
- May 24, 1999
- Decision Date
- December 10, 1999
- Product Code
- DQD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQD | Stethoscope, Electronic | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K873947 | BIO-EMG MODEL 800 | Apr 27, 1988 | Substantially Equivalent |
| K844618 | BIO-TENS | Aug 21, 1985 | Substantially Equivalent |
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