The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Apex Spx Cardial.
| Device ID | K932673 |
| 510k Number | K932673 |
| Device Name: | APEX SPX CARDIAL |
| Classification | Camera, Scintillation (gamma) |
| Applicant | ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Contact | Rochelle M Sobel |
| Correspondent | Rochelle M Sobel ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-02 |
| Decision Date | 1994-02-18 |