Sensis

Computer, Diagnostic, Programmable

Siemens Medical Solutions, Inc.

The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for Sensis.

Pre-market Notification Details

• Device ID: K150493
• 510k Number: K150493
• Device Name: Sensis
• Classification: Computer, Diagnostic, Programmable
• Applicant: Siemens Medical Solutions, Inc. 51 Valley Stream Parkway Malvern, PA 19355
• Contact: Patricia D Jones
• Correspondent: Patricia D Jones; Siemens Medical Solutions, Inc. 51 Valley Stream Parkway Malvern, PA 19355
• Product Code: DQK
• CFR Regulation Number: 870.1425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-02-25
• Decision Date: 2015-06-30
• Summary: summary