Submission Details
| 510(k) Number | K152993 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 13, 2015 |
| Decision Date | January 12, 2016 |
| Days to Decision | 91 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
MUSE Cardiology Information System
Jan 2016
Decision
91d
Days
Class 2
Risk
About This 510(k) Submission
K152993 is an FDA 510(k) clearance for the MUSE Cardiology Information System, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Ge Medical Systems Information Technologies, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on January 12, 2016, 91 days after receiving the submission on October 13, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.
Device Classification
| Product Code | DQK — Computer, Diagnostic, Programmable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1425 |
Manufacturer
Ge Medical Systems Information Technologies, Inc.
Wauwatosa, WI · US
AMY YANG
31 submissions
31 cleared
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