REVOLUTIONFULL FACE MASK

Ventilator, Non-continuous (respirator)

RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP

The following data is part of a premarket notification filed by Respironics Inc., Sleep & Home Respiratory Group with the FDA for Revolutionfull Face Mask.

Pre-market Notification Details

• Device ID: K082866
• 510k Number: K082866
• Device Name: REVOLUTIONFULL FACE MASK
• Classification: Ventilator, Non-continuous (respirator)
• Applicant: RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. Murrysville, PA 15668
• Contact: Andrew Zeltwanger
• Correspondent: Andrew Zeltwanger; RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. Murrysville, PA 15668
• Product Code: BZD
• CFR Regulation Number: 868.5905 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-09-29
• Decision Date: 2009-01-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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