The following data is part of a premarket notification filed by Sterling Diagnostic Imaging, Inc. with the FDA for Raven Dry Printer.
Device ID | K972660 |
510k Number | K972660 |
Device Name: | RAVEN DRY PRINTER |
Classification | Camera, Multi Format, Radiological |
Applicant | STERLING DIAGNOSTIC IMAGING, INC. P.O. BOX 6101 BUILDING 600/MAILBOX 630 Newark, DE 19714 -6101 |
Contact | Timothy W Capehart |
Correspondent | Timothy W Capehart STERLING DIAGNOSTIC IMAGING, INC. P.O. BOX 6101 BUILDING 600/MAILBOX 630 Newark, DE 19714 -6101 |
Product Code | LMC |
CFR Regulation Number | 892.2040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-07-16 |
Decision Date | 1997-11-10 |
Summary: | summary |