FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTEMIS LIGHT ENGINE
K Number: K141164
·
Decision Mar 16, 2015
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
8
Applicant Total
2
Review Days
315
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Basic Information
- Device Name
- ARTEMIS LIGHT ENGINE
- K Number
- K141164
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quest Medical Imaging
- Date Received
- May 5, 2014
- Decision Date
- March 16, 2015
- Product Code
- NTN
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| NTN | Led Light Source | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Quest Medical Imaging
| K Number | Device Name | ||
|---|---|---|---|
| K143474 | Artemis Hand Held Imaging System | Jun 30, 2015 | Substantially Equivalent |