Submission Details
| 510(k) Number | K221056 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 11, 2022 |
| Decision Date | July 06, 2023 |
| Days to Decision | 451 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
K221056 - ARGUS PB-3000
(FDA 510(k) Clearance)
Jul 2023
Decision
451d
Days
Class 2
Risk
K221056 is an FDA 510(k) clearance for the ARGUS PB-3000. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX).
Submitted by Schiller AG (Baar Zug, CH). The FDA issued a Cleared decision on July 6, 2023, 451 days after receiving the submission on April 11, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
Device Classification
| Product Code | MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1025 |
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