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Clearview Blower/Mister

by Dlp, Inc. 510(k)

Active United States Open recall

510(k) K973485

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK973485 Date8 Dec 1997ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1794-2024 FDA Class II initiated 19 Mar 2024

    Potential for unsealed sterile packing.

Specification

510(k)

510(k) Number
FDA Product Code
FQH
Device Class
Class II
Regulation
21 CFR Part 880.5475
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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