FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PODIOSCOPE BY ARROW
K Number: K820119
·
Decision Feb 18, 1982
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
15
Applicant Total
2
Review Days
31
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PODIOSCOPE BY ARROW
- K Number
- K820119
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1610
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Arrow X-Ray Corp.
- Date Received
- January 18, 1982
- Decision Date
- February 18, 1982
- Product Code
- KPW
- 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 |
|---|---|---|---|
| KPW | Device, Beam Limiting, X-Ray, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPW), ordered by most recent decision date.
LUMOS, MODEL R 72B
FDA 510(k)
FDA Class 2
·Radiology
COLLIMATOR, MODEL M-38
FDA 510(k)
FDA Class 2
·Radiology
R 72
FDA 510(k)
FDA Class 2
·Radiology
BLA-800A
FDA 510(k)
FDA Class 2
·Radiology
R 302
FDA 510(k)
FDA Class 2
·Radiology
P2020-8-0 BEAM-LIMITING DEVICE
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Arrow X-Ray Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K827069 | PODIOSCOPE BY ARROW | Feb 18, 1982 | Substantially Equivalent |