PeekMed

System, Image Processing, Radiological

Peek Health, S.A.

The following data is part of a premarket notification filed by Peek Health, S.a. with the FDA for Peekmed.

Pre-market Notification Details

• Device ID: K182464
• 510k Number: K182464
• Device Name: PeekMed
• Classification: System, Image Processing, Radiological
• Applicant: Peek Health, S.A. Praca Conde De Agrolongo, N 123 Braga, PT 4700-312
• Contact: Sara Silva
• Correspondent: Rachel Paul; Emergo Europe Consulting Prinsessegracht 20 The Hague, NL 2514 Ap
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-09-10
• Decision Date: 2018-10-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05600120304801	K182464	000