The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Strait'map Option.
Device ID | K973368 |
510k Number | K973368 |
Device Name: | STRAIT'MAP OPTION |
Classification | System, X-ray, Angiographic |
Applicant | GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
Contact | Larry A Kroger |
Correspondent | Larry A Kroger GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
Product Code | IZI |
CFR Regulation Number | 892.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-08 |
Decision Date | 1997-10-17 |
Summary: | summary |