The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Ventri 1.1.
Device ID | K080124 |
510k Number | K080124 |
Device Name: | VENTRI 1.1 |
Classification | System, Tomography, Computed, Emission |
Applicant | GE MEDICAL SYSTEMS F.I. HAIFA 4 HAYOZMA ST. Tirat Hacarmel, IL 30200 |
Contact | Laurence Bigio |
Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2008-01-17 |
Decision Date | 2008-01-31 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840682105286 | K080124 | 000 |