SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896

Nebulizer (direct Patient Interface)

HUDSON RESPIRATORY CARE, INC.

The following data is part of a premarket notification filed by Hudson Respiratory Care, Inc. with the FDA for Side Draft Neb-u-mist Nebulizer, Model 41896.

Pre-market Notification Details

• Device ID: K994352
• 510k Number: K994352
• Device Name: SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896
• Classification: Nebulizer (direct Patient Interface)
• Applicant: HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. P.O. BOX 9020 Temecula, CA 92589 -9020
• Contact: Jeannie Denning
• Correspondent: Jeannie Denning; HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. P.O. BOX 9020 Temecula, CA 92589 -9020
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-12-23
• Decision Date: 2000-03-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
24026704627220	K994352	000
24026704594843	K994352	000
24026704390094	K994352	000
24026704645767	K994352	000