INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456

Nebulizer (direct Patient Interface)

RESPIRONICS NEW JERSEY, INC.

The following data is part of a premarket notification filed by Respironics New Jersey, Inc. with the FDA for Inspiration Elite Nebulizer Compressor, With Nebulizer, Model Hs456.

Pre-market Notification Details

• Device ID: K042655
• 510k Number: K042655
• Device Name: INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456
• Classification: Nebulizer (direct Patient Interface)
• Applicant: RESPIRONICS NEW JERSEY, INC. 41 CANFIELD RD. Cedar Grove, NJ 07009
• Contact: Lauren Ziegler
• Correspondent: Ned Devine; ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2004-09-28
• Decision Date: 2004-10-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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