All-in-One Health Monitor, PC-303— 510(k) K170047

Name: FDA 510(k) clearance K170047
Creator: U.S. Food and Drug Administration
Published: 2017-09-09

Substantially Equivalent

Shenzhen Creative Industry Co., Ltd.

FDA 510(k) clearance K170047 for All-in-One Health Monitor, PC-303, Substantially Equivalent on 2017-09-09. Applicant: Shenzhen Creative Industry Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Creative Industry Co., Ltd.
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2017-01-05
Decision date: 2017-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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K172792 — Handheld Pulse Oximeter, Model SP-202018-11-13
K150093 — Pulse Oximeter, Models PC-66A +16 more2015-06-03
K123711 — PATIENT MONITOR2013-10-01

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.