CARDIOSCOPE

System, Measurement, Blood-pressure, Non-invasive

PULSECOR LIMITED

The following data is part of a premarket notification filed by Pulsecor Limited with the FDA for Cardioscope.

Pre-market Notification Details

• Device ID: K121266
• 510k Number: K121266
• Device Name: CARDIOSCOPE
• Classification: System, Measurement, Blood-pressure, Non-invasive
• Applicant: PULSECOR LIMITED 1468 HARWELL AVE. Crofton, MD 21114
• Contact: E.j. Smith
• Correspondent: E.j. Smith; PULSECOR LIMITED 1468 HARWELL AVE. Crofton, MD 21114
• Product Code: DXN
• CFR Regulation Number: 870.1130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-04-26
• Decision Date: 2012-12-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
09351405001019	K121266	000