7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS

Ventilator, Non-continuous (respirator)

HANS RUDOLPH, INC.

The following data is part of a premarket notification filed by Hans Rudolph, Inc. with the FDA for 7600 Series Multi-patient Multi-use Oro-nasal Cpap/nppv Masks.

Pre-market Notification Details

• Device ID: K030822
• 510k Number: K030822
• Device Name: 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS
• Classification: Ventilator, Non-continuous (respirator)
• 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: BZD
• CFR Regulation Number: 868.5905 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-03-14
• Decision Date: 2003-06-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817136027180	K030822	000
00874750002986	K030822	000
00874750003969	K030822	000
00874750004027	K030822	000
00874750004058	K030822	000
00874750001132	K030822	000
00874750001101	K030822	000
00874750001118	K030822	000
00874750001125	K030822	000
00874750000999	K030822	000
00874750001002	K030822	000
00874750001019	K030822	000
00874750001026	K030822	000
00874750001033	K030822	000
00874750001293	K030822	000
00874750001316	K030822	000
00874750002528	K030822	000
00874750002535	K030822	000
00874750002979	K030822	000
00874750002917	K030822	000
00874750002900	K030822	000
00817136027197	K030822	000
00817136027227	K030822	000
00817136027272	K030822	000
00817136027289	K030822	000
00817136027302	K030822	000
00874750001347	K030822	000
00874750001354	K030822	000
00874750001361	K030822	000
00874750001378	K030822	000
00874750001385	K030822	000
00874750001408	K030822	000
00874750001415	K030822	000
00874750001439	K030822	000
00874750001446	K030822	000
00874750002573	K030822	000
00874750002887	K030822	000
00874750002894	K030822	000
00874750002542	K030822	000
00874750002559	K030822	000
00874750002566	K030822	000
00874750003648	K030822	000
00874750003655	K030822	000
00874750003662	K030822	000
00874750003679	K030822	000
00874750003686	K030822	000
00874750003693	K030822	000
00874750003709	K030822	000
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00874750003723	K030822	000
00874750003730	K030822	000
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00874750004591	K030822	000
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00874750005222	K030822	000
00874750003631	K030822	000
00874750003624	K030822	000
00874750003617	K030822	000
00874750002924	K030822	000
00874750002931	K030822	000
00874750002948	K030822	000
00874750002955	K030822	000
00874750002962	K030822	000
00874750002993	K030822	000
00874750003006	K030822	000
00874750003013	K030822	000
00874750003020	K030822	000
00874750003037	K030822	000
00874750003044	K030822	000
00874750003556	K030822	000
00874750003563	K030822	000
00874750003570	K030822	000
00874750003587	K030822	000
00874750003594	K030822	000
00874750003600	K030822	000
00874750005239	K030822	000