The following data is part of a premarket notification filed by Job Corporation with the FDA for Porta 100hf.
Device ID | K122697 |
510k Number | K122697 |
Device Name: | PORTA 100HF |
Classification | System, X-ray, Mobile |
Applicant | JOB CORPORATION 1411 W. 190TH STREET SUITE 120 Gardena, CA 92048 |
Contact | Takahiro Haruyama |
Correspondent | Takahiro Haruyama JOB CORPORATION 1411 W. 190TH STREET SUITE 120 Gardena, CA 92048 |
Product Code | IZL |
CFR Regulation Number | 892.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-04 |
Decision Date | 2012-10-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00458237384007 | K122697 | 000 |
04582373840071 | K122697 | 000 |