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
10190752182011	K031745	000
50190752184549	K031745	000
50190752184556	K031745	000
50190752151893	K031745	000
50190752151985	K031745	000
50190752152685	K031745	000
20190752152783	K031745	000
50190752156539	K031745	000
10190752161917	K031745	000
10190752161924	K031745	000
50190752184518	K031745	000
50190752184464	K031745	000
10190752164871	K031745	000
50190752144444	K031745	000
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10190752176324	K031745	000
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50190752184440	K031745	000
50190752184457	K031745	000
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50190752184495	K031745	000
20846446004363	K031745	000
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70846446005891	K031745	000
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50190752184471	K031745	000
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50190752184525	K031745	000
50190752184532	K031745	000
50190752151923	K031745	000
50190752151930	K031745	000
70846446005907	K031745	000