FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXHALE DOPPLER SYSTEM
K Number: K010649
·
Decision Mar 20, 2001
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
1117
Applicant Total
11
Review Days
15
Basic Information
- Device Name
- EXHALE DOPPLER SYSTEM
- K Number
- K010649
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BRONCUS TECHNOLOGIES, INC.
- Date Received
- March 5, 2001
- Decision Date
- March 20, 2001
- Product Code
- IYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by BRONCUS TECHNOLOGIES, INC.
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|---|---|---|---|
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| K093423 | LUNGPOINT PROCEDURE PLANNING | Nov 17, 2009 | Substantially Equivalent |
| K091160 | LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM | May 5, 2009 | Substantially Equivalent |
| K090853 | YIELD TISSUE SAMPLER | Apr 7, 2009 | Substantially Equivalent |
| K090743 | YIELD MINI DOPPLER SYSTEM | Apr 3, 2009 | Substantially Equivalent |
| K090095 | LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM | Mar 13, 2009 | Substantially Equivalent |
| K013111 | EXHALE PROBE | Oct 1, 2001 | Substantially Equivalent |
| K011267 | EXHALE RF PROBE | May 8, 2001 | Substantially Equivalent |
| K993900 | COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115 | Jan 28, 2000 | Substantially Equivalent |
| K980046 | BRONCHIAL CATHETER SYSTEM | May 1, 1998 | Substantially Equivalent |