FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC
K Number: K050220
·
Decision Feb 10, 2005
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
226
Applicant Total
50
Review Days
10
Basic Information
- Device Name
- EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC
- K Number
- K050220
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OLYMPUS MEDICAL SYSTEMS CORPORATION
- Date Received
- January 31, 2005
- Decision Date
- February 10, 2005
- Product Code
- EOQ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)
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InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; InsightersTM Insight Workstation iS-PF1.
FDA 510(k)
FDA Class 2
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|---|---|---|---|
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| K112680 | EVIS EXERA III VIDEO SYSTEM | Feb 16, 2012 | Substantially Equivalent |
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| K102763 | SYSTEMS INTEGRATION | Feb 15, 2011 | Substantially Equivalent |
| K102379 | LTF-Y0009; MAJ-YOO41; XOEV-3D1 | Jan 5, 2011 | Substantially Equivalent |
| K102059 | AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017 | Oct 8, 2010 | Substantially Equivalent |