SunTech CT40 Spot-check Vital Signs Device

System, Measurement, Blood-pressure, Non-invasive

SUNTECH MEDICAL

The following data is part of a premarket notification filed by Suntech Medical with the FDA for Suntech Ct40 Spot-check Vital Signs Device.

Pre-market Notification Details

• Device ID: K160439
• 510k Number: K160439
• Device Name: SunTech CT40 Spot-check Vital Signs Device
• Classification: System, Measurement, Blood-pressure, Non-invasive
• Applicant: SUNTECH MEDICAL 507 AIRPORT BLVD SUITE 117 Morrisville, NC 27560
• Contact: Chuck Setzer
• Correspondent: Chuck Setzer; SUNTECH MEDICAL 507 AIRPORT BLVD SUITE 117 Morrisville, NC 27560
• Product Code: DXN
• Subsequent Product Code: DQA
• Subsequent Product Code: FLL
• CFR Regulation Number: 870.1130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-02-17
• Decision Date: 2016-07-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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