FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM
K Number: K132475
·
Decision May 7, 2014
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
60
Applicant Total
3
Review Days
273
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Basic Information
- Device Name
- FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM
- K Number
- K132475
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fluoptics
- Date Received
- August 7, 2013
- Decision Date
- May 7, 2014
- Product Code
- OWN
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| OWN | Confocal Optical Imaging | FDA class 2 | Gastroenterology, Urology |
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