WESTMED CIRCULARIE PEP DEVICES

Attachment, Breathing, Positive End Expiratory Pressure

WESTMED INTL.

The following data is part of a premarket notification filed by Westmed Intl. with the FDA for Westmed Circularie Pep Devices.

Pre-market Notification Details

• Device ID: K955047
• 510k Number: K955047
• Device Name: WESTMED CIRCULARIE PEP DEVICES
• Classification: Attachment, Breathing, Positive End Expiratory Pressure
• Applicant: WESTMED INTL. 3351 EAST HEMISPHERE LOOP Tucson, AZ 85706
• Contact: Lynn D Hayse
• Correspondent: Lynn D Hayse; WESTMED INTL. 3351 EAST HEMISPHERE LOOP Tucson, AZ 85706
• Product Code: BYE
• CFR Regulation Number: 868.5965 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-11-03
• Decision Date: 1996-03-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00709078008825	K955047	000