FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01
K Number: K052209
·
Decision Sep 6, 2005
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
9
Review Days
22
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Basic Information
- Device Name
- VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01
- K Number
- K052209
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vascular Control Systems, Inc.
- Date Received
- August 15, 2005
- Decision Date
- September 6, 2005
- Product Code
- DPW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
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Other Clearances by Vascular Control Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K060573 | BURBANK TENACULUM | Apr 21, 2006 | Substantially Equivalent |
| K032125 | CSTAT, MODELS 09-0014-01 AND 09-0014-02 | Feb 9, 2004 | Substantially Equivalent |
| K031812 | TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 | Dec 12, 2003 | Substantially Equivalent |
| K031358 | TRANSVAGINAL DOPPLER PROBE | May 9, 2003 | Substantially Equivalent |
| K030078 | BURBANK TENACULUM, MODEL 09-0011-01 | Jan 24, 2003 | Substantially Equivalent |
| K023154 | VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02 | Dec 20, 2002 | Substantially Equivalent |
| K023024 | TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 | Sep 26, 2002 | Substantially Equivalent |
| K011863 | VCS-A SERIES CLAMP | Feb 15, 2002 | Substantially Equivalent |