The following data is part of a premarket notification filed by Jpi Healthcare Co., Ltd with the FDA for Jpi Automatic X-ray Film Processor.
| Device ID | K950043 |
| 510k Number | K950043 |
| Device Name: | JPI AUTOMATIC X-RAY FILM PROCESSOR |
| Classification | Processor, Radiographic-film, Automatic |
| Applicant | JPI HEALTHCARE CO., LTD 41-02 BELL BLVD. SUITE LL3 Bayside, NY 11361 |
| Contact | Ki M Lee |
| Correspondent | Ki M Lee JPI HEALTHCARE CO., LTD 41-02 BELL BLVD. SUITE LL3 Bayside, NY 11361 |
| Product Code | IXW |
| CFR Regulation Number | 892.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-05 |
| Decision Date | 1995-05-10 |