BLOOD GLUCOSE MONITORING SYSTEM

System, Test, Blood Glucose, Over The Counter

AMERICAN HEALTHCARE INC.

The following data is part of a premarket notification filed by American Healthcare Inc. with the FDA for Blood Glucose Monitoring System.

Pre-market Notification Details

• Device ID: K043543
• 510k Number: K043543
• Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Classification: System, Test, Blood Glucose, Over The Counter
• Applicant: AMERICAN HEALTHCARE INC. 304 PARK AVENUE SOUTH SUITE 218 New York, NY 10010 -4301
• Contact: Edward Letko
• Correspondent: Edward Letko; AMERICAN HEALTHCARE INC. 304 PARK AVENUE SOUTH SUITE 218 New York, NY 10010 -4301
• Product Code: NBW
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-12-20
• Decision Date: 2005-04-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885502001041	K043543	000
00885502000044	K043543	000