The following data is part of a premarket notification filed by Jpi Healthcare Co., Ltd with the FDA for Jpi Intensifying Screen.
| Device ID | K954161 |
| 510k Number | K954161 |
| Device Name: | JPI INTENSIFYING SCREEN |
| Classification | Screen, Intensifying, Radiographic |
| 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 | EAM |
| CFR Regulation Number | 892.1960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-05 |
| Decision Date | 1996-02-02 |