The following data is part of a premarket notification filed by Arrow X-ray Corp. with the FDA for Podioscope By Arrow.
Device ID | K820119 |
510k Number | K820119 |
Device Name: | PODIOSCOPE BY ARROW |
Classification | Device, Beam Limiting, X-ray, Diagnostic |
Applicant | ARROW X-RAY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KPW |
CFR Regulation Number | 892.1610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-18 |
Decision Date | 1982-02-18 |