HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS

Ventilator, Continuous, Facility Use

HANS RUDOLPH, INC.

The following data is part of a premarket notification filed by Hans Rudolph, Inc. with the FDA for Hans Rudolph 7500 Series Reusable Oro-nasal Niv Masks.

Pre-market Notification Details

• Device ID: K030515
• 510k Number: K030515
• Device Name: HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS
• Classification: Ventilator, Continuous, Facility Use
• Applicant: HANS RUDOLPH, INC. 7200 WYANDOTTE Kansas City, MO 64114
• Contact: Kevin Rudolph
• Correspondent: Kevin Rudolph; HANS RUDOLPH, INC. 7200 WYANDOTTE Kansas City, MO 64114
• Product Code: CBK
• CFR Regulation Number: 868.5895 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-02-19
• Decision Date: 2003-05-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00874750000609	K030515	000
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