The following data is part of a premarket notification filed by Source-ray, Inc. with the FDA for Sr-130.
Device ID | K030494 |
510k Number | K030494 |
Device Name: | SR-130 |
Classification | System, X-ray, Mobile |
Applicant | SOURCE-RAY, INC. 167 KEYLAND CT. Bohemia, NY 11716 |
Contact | Ray Manez |
Correspondent | Ray Manez SOURCE-RAY, INC. 167 KEYLAND CT. Bohemia, NY 11716 |
Product Code | IZL |
CFR Regulation Number | 892.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-19 |
Decision Date | 2003-05-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817100020353 | K030494 | 000 |
00817100020117 | K030494 | 000 |
00868162000258 | K030494 | 000 |
00868162000241 | K030494 | 000 |