The following data is part of a premarket notification filed by Inter Medical Medizintechnik Gmbh with the FDA for Multicam 3000 Eco.
Device ID | K132347 |
510k Number | K132347 |
Device Name: | MULTICAM 3000 ECO |
Classification | System, Tomography, Computed, Emission |
Applicant | INTER MEDICAL MEDIZINTECHNIK GMBH 14 COMMERCIAL ST, UNIT B Branford, CT 06405 |
Contact | William Carroll |
Correspondent | William Carroll INTER MEDICAL MEDIZINTECHNIK GMBH 14 COMMERCIAL ST, UNIT B Branford, CT 06405 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-29 |
Decision Date | 2013-11-20 |
Summary: | summary |