The following data is part of a premarket notification filed by Perkins Mfg. Co. with the FDA for Sc1000 Scan Converter.
Device ID | K926348 |
510k Number | K926348 |
Device Name: | SC1000 SCAN CONVERTER |
Classification | Device, Digital Image Storage, Radiological |
Applicant | PERKINS MFG. CO. 1510 NORTH WASHINGTON AVE. Dallas, TX 75204 |
Contact | James C Furse |
Correspondent | James C Furse PERKINS MFG. CO. 1510 NORTH WASHINGTON AVE. Dallas, TX 75204 |
Product Code | LMB |
CFR Regulation Number | 892.2010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-17 |
Decision Date | 1993-11-19 |