FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇱 Israel
EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)
K Number: K982754
·
Decision Jan 8, 1999
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
22
Applicant Total
5
Review Days
155
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Basic Information
- Device Name
- EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)
- K Number
- K982754
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4160
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- A.Stein - Regulatory Affairs Consulting
- Date Received
- August 6, 1998
- Decision Date
- January 8, 1999
- Product Code
- FWF
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| FWF | Camera, Television, Endoscopic, Without Audio | FDA class 1 | General, Plastic Surgery |
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