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Zephyr 'x-Series Patient Transfer Sled

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121929

by Diacor Inc.

Identifiers

510(k) Number
K121929 FDA 510(k)
FDA Product Code
FRZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6775 FDA 510(k)
Regulation Number
880.6775 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Zephyr 'x-Series Patient Transfer Sled by Diacor Inc. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Diacor Inc.
FDA Applicant
Diacor, Inc.

Sources (1)

  • FDA 510(k) K121929 24 fields · synced Jun 18, 2026