IMAGE3 SE DISPOSABLE FULL FACE MASK

Ventilator, Continuous, Facility Use

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Image3 Se Disposable Full Face Mask.

Pre-market Notification Details

• Device ID: K023135
• 510k Number: K023135
• Device Name: IMAGE3 SE DISPOSABLE FULL FACE MASK
• Classification: Ventilator, Continuous, Facility Use
• Applicant: RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668
• Contact: Zita A Yurko
• Correspondent: Zita A Yurko; RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668
• Product Code: CBK
• CFR Regulation Number: 868.5895 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-09-20
• Decision Date: 2003-01-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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