CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60

Humidifier, Respiratory Gas, (direct Patient Interface)

HUDSON RESPIRATORY CARE, INC.

The following data is part of a premarket notification filed by Hudson Respiratory Care, Inc. with the FDA for Conchatherm 2000 Humidification System, Models 500-00, -10, -20, -30, -40, -50, & -60.

Pre-market Notification Details

• Device ID: K001213
• 510k Number: K001213
• Device Name: CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60
• Classification: Humidifier, Respiratory Gas, (direct Patient Interface)
• Applicant: HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. P.O. BOX 9020 Temecula, CA 92589 -9020
• Contact: Dana Houghton
• Correspondent: Dana Houghton; HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. P.O. BOX 9020 Temecula, CA 92589 -9020
• Product Code: BTT
• CFR Regulation Number: 868.5450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-04-14
• Decision Date: 2000-11-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
44026704597886	K001213	000
44026704597879	K001213	000
24026704659627	K001213	000
14026704597755	K001213	000
34026704662792	K001213	000
34026704662785	K001213	000
34026704662778	K001213	000
24026704597899	K001213	000