FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120
K Number: K961301
·
Decision Jun 11, 1996
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
153
Applicant Total
6
Review Days
68
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Basic Information
- Device Name
- E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120
- K Number
- K961301
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Delphi Consulting Group
- Date Received
- April 4, 1996
- Decision Date
- June 11, 1996
- 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 Delphi Consulting Group
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|---|---|---|---|
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| K963957 | TRINITY DVT SYSTEM | Nov 4, 1997 | Substantially Equivalent |
| K970014 | TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.) | Aug 6, 1997 | Substantially Equivalent |
| K961937 | SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM | Dec 9, 1996 | Substantially Equivalent |
| K954489 | TRINITY SLEEVE(S) | Feb 22, 1996 | Substantially Equivalent |