FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
A2J MZ 45 LASER LIGHT FOR POSITIONING
K Number: K881591
·
Decision Apr 27, 1988
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
2
Applicant Total
4
Review Days
14
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Basic Information
- Device Name
- A2J MZ 45 LASER LIGHT FOR POSITIONING
- K Number
- K881591
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- A2j, Inc.
- Date Received
- April 13, 1988
- Decision Date
- April 27, 1988
- Product Code
- IWX
- 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 |
|---|---|---|---|
| IWX | Barrier, Control Panel, X-Ray, Movable | FDA class 1 | Radiology |
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