HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43

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 Hudson Rci Concha Column, Cat. No. 385-40 And Hudson Rci Circuit, Cat. No. 780-40, 780-41, 780-42, 780-43.

Pre-market Notification Details

• Device ID: K993355
• 510k Number: K993355
• Device Name: HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43
• Classification: Humidifier, Respiratory Gas, (direct Patient Interface)
• Applicant: HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. P.O. BOX 9020 Temecula, CA 92589 -9020
• Contact: Charles Mierkiewicz
• Correspondent: Charles Mierkiewicz; 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: 1999-10-06
• Decision Date: 2000-05-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
34026704628293	K993355	000
04026704597635	K993355	000