The following data is part of a premarket notification filed by Halifax Biomedical, Inc. with the FDA for Sr Suite 1.0.
Device ID | K121345 |
510k Number | K121345 |
Device Name: | SR SUITE 1.0 |
Classification | System, X-ray, Stationary |
Applicant | HALIFAX BIOMEDICAL, INC. 8870 RAVELLO CT Naples, FL 34114 |
Contact | Daniel Kamm |
Correspondent | Daniel Kamm HALIFAX BIOMEDICAL, INC. 8870 RAVELLO CT Naples, FL 34114 |
Product Code | KPR |
Subsequent Product Code | LLZ |
Subsequent Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-05-04 |
Decision Date | 2012-06-01 |
Summary: | summary |