SIGNAL

Stethoscope, Electronic

ZARGIS MEDICAL CORP.

The following data is part of a premarket notification filed by Zargis Medical Corp. with the FDA for Signal.

Pre-market Notification Details

• Device ID: K090493
• 510k Number: K090493
• Device Name: SIGNAL
• Classification: Stethoscope, Electronic
• Applicant: ZARGIS MEDICAL CORP. 2 RESEARCH WAY, 1ST FLOOR Princeton, NJ 08540
• Contact: John Kallassy
• Correspondent: John Kallassy; ZARGIS MEDICAL CORP. 2 RESEARCH WAY, 1ST FLOOR Princeton, NJ 08540
• Product Code: DQD
• CFR Regulation Number: 870.1875 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-02-25
• Decision Date: 2009-08-07
• Summary: summary