NEOPIP PATIENT CIRCUIT WITH PEEP

Attachment, Breathing, Positive End Expiratory Pressure

NEOFORCE GROUP, INC.

The following data is part of a premarket notification filed by Neoforce Group, Inc. with the FDA for Neopip Patient Circuit With Peep.

Pre-market Notification Details

• Device ID: K103833
• 510k Number: K103833
• Device Name: NEOPIP PATIENT CIRCUIT WITH PEEP
• Classification: Attachment, Breathing, Positive End Expiratory Pressure
• Applicant: NEOFORCE GROUP, INC. 35 COMMERCE DR. Ivyland, PA 18974
• Contact: Monica Ferrante
• Correspondent: Monica Ferrante; NEOFORCE GROUP, INC. 35 COMMERCE DR. Ivyland, PA 18974
• Product Code: BYE
• CFR Regulation Number: 868.5965 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-12-30
• Decision Date: 2011-04-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00854401006563	K103833	000
05055931119630	K103833	000
05055931119623	K103833	000
05055931119616	K103833	000
05055931119609	K103833	000
05055931119579	K103833	000
05055931119562	K103833	000
05055931117636	K103833	000
05055931106715	K103833	000
05055931106692	K103833	000
05055931106678	K103833	000
05055931106609	K103833	000
05055931106579	K103833	000
05055931106562	K103833	000
05055931106487	K103833	000
05055931106517	K103833	000
05055931106661	K103833	000
05055931106647	K103833	000
05055931119647	K103833	000
05055931119654	K103833	000
05055931119661	K103833	000
00854401006549	K103833	000
00854401006525	K103833	000
00854401006501	K103833	000
00854401006488	K103833	000
00854401006457	K103833	000
00854401006440	K103833	000
00854401006433	K103833	000
00854401006426	K103833	000
00854401006402	K103833	000
00854401006372	K103833	000
00854401006365	K103833	000
05055788776680	K103833	000
05055788776673	K103833	000
05055788776666	K103833	000
05055931119692	K103833	000
05055931119685	K103833	000
05055931119678	K103833	000
05055931106616	K103833	000