FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
EOS BRAND DISPOSABLE PROCTOSCOPE
K Number: K954614
·
Decision Apr 10, 1996
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
12
Applicant Total
3
Review Days
188
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Basic Information
- Device Name
- EOS BRAND DISPOSABLE PROCTOSCOPE
- K Number
- K954614
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- North Eos Industries, Inc.
- Date Received
- October 5, 1995
- Decision Date
- April 10, 1996
- Product Code
- GCP
- 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 |
|---|---|---|---|
| GCP | Endoscope, Ac-Powered And Accessories | FDA class 2 | Gastroenterology, Urology |
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