ROSA ONE Brain Application

Neurological Stereotaxic Instrument

MEDTECH S.A.

The following data is part of a premarket notification filed by Medtech S.a. with the FDA for Rosa One Brain Application.

Pre-market Notification Details

• Device ID: K182417
• 510k Number: K182417
• Device Name: ROSA ONE Brain Application
• Classification: Neurological Stereotaxic Instrument
• Applicant: MEDTECH S.A. ZAC Eureka - 900 Rue Du Mas De Verchant Montpellier, FR 34000
• Contact: Serge Tabet
• Correspondent: Serge Tabet; MEDTECH S.A. ZAC Eureka - 900 Rue Du Mas De Verchant Montpellier, FR 34000
• Product Code: HAW
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-09-05
• Decision Date: 2019-02-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03760244032621	K182417	000
03760244032348	K182417	000
03760244032331	K182417	000
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03760244033031	K182417	000