Affinity

System, Tomography, Computed, Emission

Hermes Medical Solutions AB

The following data is part of a premarket notification filed by Hermes Medical Solutions Ab with the FDA for Affinity.

Pre-market Notification Details

• Device ID: K202882
• 510k Number: K202882
• Device Name: Affinity
• Classification: System, Tomography, Computed, Emission
• Applicant: Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm, SE 11251
• Contact: Joakim Arwidson
• Correspondent: Joakim Arwidson; Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm, SE 11251
• Product Code: KPS
• CFR Regulation Number: 892.1200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-09-28
• Decision Date: 2020-12-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00859873006165	K202882	000