The following data is part of a premarket notification filed by Gamma Medica with the FDA for Lumagem Scintillation Camera.
Device ID | K993813 |
510k Number | K993813 |
Device Name: | LUMAGEM SCINTILLATION CAMERA |
Classification | Camera, Scintillation (gamma) |
Applicant | GAMMA MEDICA 19355 BUSINESS CENTER DR., SUITE 8 Northridge, CA 91324 |
Contact | Bradley E Patt |
Correspondent | Bradley E Patt GAMMA MEDICA 19355 BUSINESS CENTER DR., SUITE 8 Northridge, CA 91324 |
Product Code | IYX |
CFR Regulation Number | 892.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-10 |
Decision Date | 2000-01-18 |
Summary: | summary |