The following data is part of a premarket notification filed by Bay X-ray, Inc. with the FDA for Rastix X-ray Table.
Device ID | K883155 |
510k Number | K883155 |
Device Name: | RASTIX X-RAY TABLE |
Classification | Table, Radiologic |
Applicant | BAY X-RAY, INC. 1630 NORTH MAIN ST., SUITE 101 Walnut Creek, CA 94596 |
Contact | Slobodan Djordjevic |
Correspondent | Slobodan Djordjevic BAY X-RAY, INC. 1630 NORTH MAIN ST., SUITE 101 Walnut Creek, CA 94596 |
Product Code | KXJ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-26 |
Decision Date | 1988-09-06 |