ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T

Stethoscope, Esophageal, With Electrical Conductors

RESPIRATORY SUPPORT PRODUCTS, INC.

The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Esophageal Stethoscope W/thermocouple Type T.

Pre-market Notification Details

• Device ID: K864043
• 510k Number: K864043
• Device Name: ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T
• Classification: Stethoscope, Esophageal, With Electrical Conductors
• 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: BZT
• CFR Regulation Number: 868.1920 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-10-16
• Decision Date: 1986-12-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10695085000259	K864043	000
10695085000242	K864043	000
10695085000235	K864043	000
10695085000228	K864043	000