BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK

Ventilator, Continuous, Non-life-supporting

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Bipap Synchrony 2 With Af531 Full Face Mask.

Pre-market Notification Details

• Device ID: K101130
• 510k Number: K101130
• Device Name: BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK
• Classification: Ventilator, Continuous, Non-life-supporting
• Applicant: RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146
• Contact: Zita A Yurko
• Correspondent: Zita A Yurko; RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146
• Product Code: MNS
• CFR Regulation Number: 868.5895 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-04-22
• Decision Date: 2010-09-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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