FDA 510(k)

HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)

Numéro K : K232820 · 2024-06-04

DemandeurOwens & Minor (O&M) Halyard, Inc.

Date de décision2024-06-04

Code produitFXX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is the device name listed in this FDA 510(k) record. The listed applicant is Owens & Minor (O&M) Halyard, Inc.. It received FDA 510(k) clearance on 2024-06-04 under 510(k) number K232820. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)?

HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is a medical device that received FDA 510(k) clearance on 2024-06-04. The listed applicant is Owens & Minor (O&M) Halyard, Inc.. The 510(k) number is K232820.

When did HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) receive FDA 510(k) clearance?

HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) received FDA 510(k) clearance on 2024-06-04, under 510(k) number K232820.

Who is the listed applicant for HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)?

The FDA 510(k) record lists Owens & Minor (O&M) Halyard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)?

The FDA product code for HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) is FXX.

Essais cliniques associés

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Autres dossiers indiquant Owens & Minor (O&M) Halyard, Inc. en tant que demandeur

K243010Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce K232824FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)K232777FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)K232807Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)K232812Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)K232806HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)

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Dispositifs connexes (Code : FXX)

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Source officielle

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