FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HL 200 ELECTRONIC STETHOSCOPE
K Number: K050169
·
Decision Apr 5, 2005
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
153
Applicant Total
60
Review Days
69
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Basic Information
- Device Name
- HL 200 ELECTRONIC STETHOSCOPE
- K Number
- K050169
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Health & Life Co., Ltd.
- Date Received
- January 26, 2005
- Decision Date
- April 5, 2005
- 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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