FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIGNAL
K Number: K090493
·
Decision Aug 7, 2009
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
153
Applicant Total
5
Review Days
163
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Basic Information
- Device Name
- SIGNAL
- K Number
- K090493
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zargis Medical Corp.
- Date Received
- February 25, 2009
- Decision Date
- August 7, 2009
- 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 Zargis Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K083309 | ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33 | Feb 13, 2009 | Substantially Equivalent |
| K060197 | ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28 | Mar 29, 2006 | Substantially Equivalent |
| K042128 | MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC) | Sep 8, 2004 | Substantially Equivalent |
| K031517 | ZARGIS ACOUSTIC CARDIOSCAN | May 26, 2004 | Substantially Equivalent |