MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE

Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass

RESPIRATORY SUPPORT PRODUCTS, INC.

The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Myocardial Temp. Sensor W/type T Thermocouple.

Pre-market Notification Details

• Device ID: K873206
• 510k Number: K873206
• Device Name: MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE
• Classification: Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass
• Applicant: RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa, CA 92626
• Contact: Anthony V Beran
• Correspondent: Anthony V Beran; RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa, CA 92626
• Product Code: DTW
• CFR Regulation Number: 870.4340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-08-14
• Decision Date: 1987-09-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10695085000549	K873206	000
20695085000539	K873206	000
20695085000522	K873206	000