ECHONET

System, Image Processing, Radiological

HEARTLAB, INC.

The following data is part of a premarket notification filed by Heartlab, Inc. with the FDA for Echonet.

Pre-market Notification Details

• Device ID: K954860
• 510k Number: K954860
• Device Name: ECHONET
• Classification: System, Image Processing, Radiological
• Applicant: HEARTLAB, INC. 146 WESTMINSTER ST. SUITE 500 Providence, RI 02903
• Contact: Richard Petrocelli
• Correspondent: Richard Petrocelli; HEARTLAB, INC. 146 WESTMINSTER ST. SUITE 500 Providence, RI 02903
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-10-23
• Decision Date: 1995-12-21