Submission Details
| 510(k) Number | K203231 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 02, 2020 |
| Decision Date | January 11, 2021 |
| Days to Decision | 70 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Switched Internal Paddles
Jan 2021
Decision
70d
Days
Class 2
Risk
About This 510(k) Submission
K203231 is an FDA 510(k) clearance for the Switched Internal Paddles, a Dc-defibrillator, Low-energy, (including Paddles) (Class II — Special Controls, product code LDD), submitted by Philips North America, LLC (Bothell, US). The FDA issued a Cleared decision on January 11, 2021, 70 days after receiving the submission on November 2, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5300.
Device Classification
| Product Code | LDD — Dc-defibrillator, Low-energy, (including Paddles) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.5300 |
Manufacturer
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