FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LCI-100 AND LCI-200 WELCH ALLYN ILLUMINATION AND IMAGING SYSTEM
K Number: K940270
·
Decision Apr 20, 1994
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
46
Applicant Total
111
Review Days
89
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Basic Information
- Device Name
- LCI-100 AND LCI-200 WELCH ALLYN ILLUMINATION AND IMAGING SYSTEM
- K Number
- K940270
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Welch Allyn, Inc.
- Date Received
- January 21, 1994
- Decision Date
- April 20, 1994
- Product Code
- GCT
- 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 |
|---|---|---|---|
| GCT | Light Source, Endoscope, Xenon Arc | FDA class 2 | Gastroenterology, Urology |
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