CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL

Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer

RESPIRATORY CARE, INC.

The following data is part of a premarket notification filed by Respiratory Care, Inc. with the FDA for Conchatherm Iii Plus Dual Heat Wire Servo Controll.

Pre-market Notification Details

• Device ID: K881625
• 510k Number: K881625
• Device Name: CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL
• Classification: Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
• Applicant: RESPIRATORY CARE, INC. 900 W. UNIVERSITY Arlington Heights, IL 60004
• Contact: Piet-hughes
• Correspondent: Piet-hughes; RESPIRATORY CARE, INC. 900 W. UNIVERSITY Arlington Heights, IL 60004
• Product Code: BZE
• CFR Regulation Number: 868.5270 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-04-12
• Decision Date: 1988-06-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
24026704659412	K881625	000
24026704659405	K881625	000
14026704659415	K881625	000
14026704659408	K881625	000