The following data is part of a premarket notification filed by Scott Imaging Intl., Inc. with the FDA for Sii 525 Ms.
Device ID | K945709 |
510k Number | K945709 |
Device Name: | SII 525 MS |
Classification | System, X-ray, Stationary |
Applicant | SCOTT IMAGING INTL., INC. 3510 COTTAGE HILL RD. Mobile, AL 36609 |
Contact | Ichael W Scott |
Correspondent | Ichael W Scott SCOTT IMAGING INTL., INC. 3510 COTTAGE HILL RD. Mobile, AL 36609 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-21 |
Decision Date | 1994-12-14 |