The following data is part of a premarket notification filed by Perkins Mfg. Co. with the FDA for Grundig Electronics Various Models.
Device ID | K915232 |
510k Number | K915232 |
Device Name: | GRUNDIG ELECTRONICS VARIOUS MODELS |
Classification | System, X-ray, Angiographic |
Applicant | PERKINS MFG. CO. 1510 NORTH WASHINGTON AVE. Dallas, TX 75204 |
Contact | Dennis P Carroll |
Correspondent | Dennis P Carroll PERKINS MFG. CO. 1510 NORTH WASHINGTON AVE. Dallas, TX 75204 |
Product Code | IZI |
CFR Regulation Number | 892.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-22 |
Decision Date | 1992-01-09 |