Submission Details
| 510(k) Number | K180534 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 28, 2018 |
| Decision Date | July 16, 2018 |
| Days to Decision | 138 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Philips IntelliVue GuardianSoftware
Jul 2018
Decision
138d
Days
Class 2
Risk
About This 510(k) Submission
K180534 is an FDA 510(k) clearance for the Philips IntelliVue GuardianSoftware, a Display, Cathode-ray Tube, Medical (Class II — Special Controls, product code DXJ), submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, DE). The FDA issued a Cleared decision on July 16, 2018, 138 days after receiving the submission on February 28, 2018. 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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