FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCULITE SSL
K Number: K923619
·
Decision Nov 16, 1992
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
27
Applicant Total
3
Review Days
118
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Basic Information
- Device Name
- ACCULITE SSL
- K Number
- K923619
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.5780
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Alignment Systems
- Date Received
- July 21, 1992
- Decision Date
- November 16, 1992
- 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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