MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE

Thermometer, Electronic, Clinical

RESPIRATORY SUPPORT PRODUCTS, INC.

The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Myocardinal Temperature Sensor With Type 400 Serie.

Pre-market Notification Details

• Device ID: K920469
• 510k Number: K920469
• Device Name: MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE
• Classification: Thermometer, Electronic, Clinical
• Applicant: RESPIRATORY SUPPORT PRODUCTS, INC. 2552 MCGAW AVE. Irvine, CA 92614
• Contact: Kerry Tomic
• Correspondent: Kerry Tomic; RESPIRATORY SUPPORT PRODUCTS, INC. 2552 MCGAW AVE. Irvine, CA 92614
• Product Code: FLL
• CFR Regulation Number: 880.2910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-01-27
• Decision Date: 1992-09-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20695085000577	K920469	000
20695085000560	K920469	000
20695085000553	K920469	000