The following data is part of a premarket notification filed by Bay X-ray, Inc. with the FDA for Himobilix 2n.
| Device ID | K883161 |
| 510k Number | K883161 |
| Device Name: | HIMOBILIX 2N |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| 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 | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-26 |
| Decision Date | 1988-10-21 |