THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104

Percussor, Powered-electric

ADVANCED RESPIRATORY

The following data is part of a premarket notification filed by Advanced Respiratory with the FDA for The Vest Airway Clearance System, Model 104.

Pre-market Notification Details

• Device ID: K024309
• 510k Number: K024309
• Device Name: THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104
• Classification: Percussor, Powered-electric
• Applicant: ADVANCED RESPIRATORY 1020 WEST COUNTY RD. F St. Paul, MN 55126
• Contact: Eric J Larson
• Correspondent: N.e. Devine; ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548
• Product Code: BYI
• CFR Regulation Number: 868.5665 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2002-12-24
• Decision Date: 2003-02-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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