TRUBLUE NASAL MASK

Ventilator, Non-continuous (respirator)

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Trublue Nasal Mask.

Pre-market Notification Details

• Device ID: K110405
• 510k Number: K110405
• Device Name: TRUBLUE NASAL MASK
• Classification: Ventilator, Non-continuous (respirator)
• Applicant: RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668
• Contact: Michelle Brinker
• Correspondent: Michelle Brinker; RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668
• Product Code: BZD
• CFR Regulation Number: 868.5905 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-02-14
• Decision Date: 2011-06-06
• Summary: summary

NIH GUDID Devices

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