FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
36-101 XDS111 XENON DELIVERY/TRAP SYSTEM
K Number: K860504
·
Decision Apr 4, 1986
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
39
Applicant Total
40
Review Days
52
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Basic Information
- Device Name
- 36-101 XDS111 XENON DELIVERY/TRAP SYSTEM
- K Number
- K860504
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1760
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Victoreen, Inc.
- Date Received
- February 11, 1986
- Decision Date
- April 4, 1986
- Product Code
- ITY
- 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 |
|---|---|---|---|
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic | FDA class 1 | Radiology |
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