The following data is part of a premarket notification filed by Ziehm International, Inc. with the FDA for Mobile X-ray Unit.
| Device ID | K894021 |
| 510k Number | K894021 |
| Device Name: | MOBILE X-RAY UNIT |
| Classification | System, X-ray, Mobile |
| Applicant | ZIEHM INTERNATIONAL, INC. 4181 LATHAM ST. Riverside, CA 92501 |
| Contact | Wolfram H Klawitter |
| Correspondent | Wolfram H Klawitter ZIEHM INTERNATIONAL, INC. 4181 LATHAM ST. Riverside, CA 92501 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-06 |
| Decision Date | 1989-09-01 |