MODEL SP1465 CARDIAC OUTPUT COMPUTER

Computer, Diagnostic, Pre-programmed, Single-function

GOULD, INC.

The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Model Sp1465 Cardiac Output Computer.

Pre-market Notification Details

• Device ID: K861092
• 510k Number: K861092
• Device Name: MODEL SP1465 CARDIAC OUTPUT COMPUTER
• Classification: Computer, Diagnostic, Pre-programmed, Single-function
• Applicant: GOULD, INC. 1900 WILLIAMS DR. Oxnard, CA 93030
• Contact: Robert L Leavitt
• Correspondent: Robert L Leavitt; GOULD, INC. 1900 WILLIAMS DR. Oxnard, CA 93030
• Product Code: DXG
• CFR Regulation Number: 870.1435 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-03-24
• Decision Date: 1986-08-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884450361051	K861092	000