FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AZ 92
K Number: K931974
·
Decision Oct 8, 1993
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
27
Applicant Total
4
Review Days
169
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Basic Information
- Device Name
- AZ 92
- K Number
- K931974
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.5780
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- A2j, Inc.
- Date Received
- April 22, 1993
- Decision Date
- October 8, 1993
- Product Code
- IWE
- 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 |
|---|---|---|---|
| IWE | Monitor, Patient Position, Light-Beam | FDA class 1 | Radiology |
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