Submission Details
| 510(k) Number | K151366 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 21, 2015 |
| Decision Date | October 30, 2015 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Philips CS770 IntelliSpace Critical Care and Anesthesia
Oct 2015
Decision
162d
Days
Class 2
Risk
About This 510(k) Submission
K151366 is an FDA 510(k) clearance for the Philips CS770 IntelliSpace Critical Care and Anesthesia, a Display, Cathode-ray Tube, Medical (Class II — Special Controls, product code DXJ), submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on October 30, 2015, 162 days after receiving the submission on May 21, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2450.
Device Classification
| Product Code | DXJ — Display, Cathode-ray Tube, Medical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2450 |
Manufacturer
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