FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORWO X-RAY FILM
K Number: K920539
·
Decision Jun 30, 1992
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
33
Applicant Total
3
Review Days
146
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Basic Information
- Device Name
- ORWO X-RAY FILM
- K Number
- K920539
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1840
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Burkhart Roentgen Intl., Inc.
- Date Received
- February 5, 1992
- Decision Date
- June 30, 1992
- Product Code
- IWZ
- 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 |
|---|---|---|---|
| IWZ | Film, Radiographic | FDA class 1 | Radiology |
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