Submission Details
| 510(k) Number | K212208 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 15, 2021 |
| Decision Date | September 30, 2021 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Philips IntelliVue GuardianSoftware (Rev. E.0X)
Sep 2021
Decision
77d
Days
Class 2
Risk
About This 510(k) Submission
K212208 is an FDA 510(k) clearance for the Philips IntelliVue GuardianSoftware (Rev. E.0X), 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 September 30, 2021, 77 days after receiving the submission on July 15, 2021. 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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