INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION

Ventilator, Non-continuous (respirator)

SENSORMEDICS CORP.

The following data is part of a premarket notification filed by Sensormedics Corp. with the FDA for Infant Flow Plus Infant Cpap System With Sipap Function.

Pre-market Notification Details

• Device ID: K031745
• 510k Number: K031745
• Device Name: INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
• Classification: Ventilator, Non-continuous (respirator)
• Applicant: SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645
• Contact: Earl W Draper
• Correspondent: Earl W Draper; SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645
• Product Code: BZD
• CFR Regulation Number: 868.5905 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-06-05
• Decision Date: 2004-02-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10846446061895	K031745	000
50190752184464	K031745	000
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