510(k) K820119
K820119 is an FDA 510(k) premarket notification submitted by Arrow X-Ray Corp. for the device "PODIOSCOPE BY ARROW". The FDA issued a decision of Substantially Equivalent on Feb 18, 1982. The device falls under product code KPW (Device, Beam Limiting, X-Ray, Diagnostic), a Class II device regulated under 21 CFR 892.1610. Arrow X-Ray Corp. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 18, 1982
- Date Received
- Jan 18, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Beam Limiting, X-Ray, Diagnostic
- Device Class
- Class II
- Regulation Number
- 892.1610
- Review Panel
- RA
- Submission Type
- 510(k) Exempt