The following data is part of a premarket notification filed by Portable Power Systems, Inc. with the FDA for Replacement Batery For Ge Amx-4 Port. X-ray Mach..
Device ID | K931483 |
510k Number | K931483 |
Device Name: | REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH. |
Classification | System, X-ray, Mobile |
Applicant | PORTABLE POWER SYSTEMS, INC. 1949 TEE LN. Castle Rock, CO 80104 |
Contact | Norman A Premo |
Correspondent | Norman A Premo PORTABLE POWER SYSTEMS, INC. 1949 TEE LN. Castle Rock, CO 80104 |
Product Code | IZL |
CFR Regulation Number | 892.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-24 |
Decision Date | 1994-02-17 |