MICRO MIST(TM) NEBULIZER

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 Micro Mist(tm) Nebulizer.

Pre-market Notification Details

• Device ID: K930525
• 510k Number: K930525
• Device Name: MICRO MIST(TM) NEBULIZER
• 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: 1993-02-02
• Decision Date: 1993-09-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
24026704390605	K930525	000
24026704581621	K930525	000
24026704581638	K930525	000
24026704595895	K930525	000
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24026704390629	K930525	000
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24026704627190	K930525	000
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34026704642992	K930525	000
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34026704595939	K930525	000
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44026704595912	K930525	000