Palm Bladder Scanner - PBSV7.1— 510(k) K210591

Name: FDA 510(k) clearance K210591
Creator: U.S. Food and Drug Administration
Published: 2021-06-09

Substantially Equivalent

Mianyang Meike Electronic Equipment Co., Ltd.

FDA 510(k) clearance K210591 for Palm Bladder Scanner - PBSV7.1, Substantially Equivalent on 2021-06-09. Applicant: Mianyang Meike Electronic Equipment Co., Ltd.. Device class: 2.

Clearance details

Applicant: Mianyang Meike Electronic Equipment Co., Ltd.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2021-03-01
Decision date: 2021-06-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Mianyang, CN

Download summary PDF View on FDA.gov ↗

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K191307 — Palm Bladder Scanner - PBSV5.12019-06-05
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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.