FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROSCOPES AND ADSCOPES
K Number: K935944
·
Decision Mar 3, 1994
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
27
Applicant Total
39
Review Days
80
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Basic Information
- Device Name
- PROSCOPES AND ADSCOPES
- K Number
- K935944
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- American Diagnostic Corp.
- Date Received
- December 13, 1993
- Decision Date
- March 3, 1994
- Product Code
- LDE
- 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 |
|---|---|---|---|
| LDE | Stethoscope, Manual | FDA class 1 | Cardiovascular |
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| K060321 | ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK | May 15, 2006 | Substantially Equivalent |
| K012304 | ADC 656 ELECTRONIC STETHOSCOPE | Nov 1, 2001 | Substantially Equivalent |
| K962655 | ANEROID AND MERCURIAL SPHYGMOMANOMETERS | Jan 27, 1997 | Substantially Equivalent |
| K940686 | ELECTRONIC THERMOMETERS | Jul 8, 1994 | Substantially Equivalent |
| K932145 | COAGULATION REFERENCE PLASMA, NORMAL | Oct 18, 1993 | Substantially Equivalent |
| K894169 | BIOTEL MICROALBUMINURIA (TM) | Sep 18, 1989 | Substantially Equivalent |
| K893608 | ACTICHROME ATIII KIT | Jun 23, 1989 | Substantially Equivalent |
| K884941 | ACTICLOT C KIT | Mar 13, 1989 | Substantially Equivalent |