FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STETHOSCOPE, NURSESCOPE TYPE
K Number: K771581
·
Decision Aug 26, 1977
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
153
Applicant Total
6
Review Days
8
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Basic Information
- Device Name
- STETHOSCOPE, NURSESCOPE TYPE
- K Number
- K771581
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Swartz Medical Equipment
- Date Received
- August 18, 1977
- Decision Date
- August 26, 1977
- 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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Other Clearances by Swartz Medical Equipment
| K Number | Device Name | ||
|---|---|---|---|
| K771502 | ANEROID SPHYGMOMETER | Aug 30, 1977 | Substantially Equivalent |
| K771501 | ANEROID SPHYGMOMETER | Aug 30, 1977 | Substantially Equivalent |
| K771506 | STETHOSCOPE | Aug 26, 1977 | Substantially Equivalent |
| K771505 | STETHOSCOPE | Aug 26, 1977 | Substantially Equivalent |
| K771504 | STETHOSCOPE | Aug 26, 1977 | Substantially Equivalent |