MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP

System, Measurement, Blood-pressure, Non-invasive

MICROLIFE CORP.

The following data is part of a premarket notification filed by Microlife Corp. with the FDA for Microlife Upper Arm Blood Pressure Monitor, Model Bp-3bto-ap.

Pre-market Notification Details

• Device ID: K041411
• 510k Number: K041411
• Device Name: MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP
• Classification: System, Measurement, Blood-pressure, Non-invasive
• Applicant: MICROLIFE CORP. 55 Northern Blvd. Suite 200 Great Neck, NY 11021
• Contact: Susan D Goldstein
• Correspondent: Susan D Goldstein; MICROLIFE CORP. 55 Northern Blvd. Suite 200 Great Neck, NY 11021
• Product Code: DXN
• CFR Regulation Number: 870.1130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-05-27
• Decision Date: 2004-07-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00634782584641	K041411	000
00634782576196	K041411	000
00634782576189	K041411	000
00634782074869	K041411	000
00634782576110	K041411	000
00634782576103	K041411	000
00634782562939	K041411	000
00634782095215	K041411	000