REMSTAR SE

Ventilator, Non-continuous (respirator)

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Remstar Se.

Pre-market Notification Details

• Device ID: K130077
• 510k Number: K130077
• Device Name: REMSTAR SE
• Classification: Ventilator, Non-continuous (respirator)
• Applicant: RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146
• Contact: Frank Kadi
• Correspondent: Frank Kadi; RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146
• Product Code: BZD
• CFR Regulation Number: 868.5905 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-01-14
• Decision Date: 2013-05-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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