The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Ge Ct-pet System.
Device ID | K010641 |
510k Number | K010641 |
Device Name: | GE CT-PET SYSTEM |
Classification | System, X-ray, Tomography, Computed |
Applicant | GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
Contact | D Duersteler |
Correspondent | Reiner Krumme TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2001-03-05 |
Decision Date | 2001-03-30 |