FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR
K Number: K972130
·
Decision Oct 9, 1997
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
11
Applicant Total
1
Review Days
125
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Basic Information
- Device Name
- DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR
- K Number
- K972130
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1620
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fairmontmedical
- Date Received
- June 6, 1997
- Decision Date
- October 9, 1997
- Product Code
- IZJ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IZJ | Camera, X-Ray, Fluorographic, Cine Or Spot | FDA class 2 | Radiology |
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