ZEPHYR 'X-SERIES PATIENT TRANSFER SLED— 510(k) K121929

Name: FDA 510(k) clearance K121929
Creator: U.S. Food and Drug Administration
Published: 2013-01-17

Substantially Equivalent

Diacor, Inc.

FDA 510(k) clearance K121929 for ZEPHYR 'X-SERIES PATIENT TRANSFER SLED, Substantially Equivalent on 2013-01-17. Applicant: Diacor, Inc.. Device class: 2.

Clearance details

Applicant: Diacor, Inc.
Product code: Code FRZ
Device class: Class 2
Regulation: 21 CFR 880.6775
Advisory panel: General Hospital
Date received: 2012-07-02
Decision date: 2013-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Valley City, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FRZ

product code FRZ

Other: 1
Total: 1

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.