PRIMUS

Tomography, Optical Coherence

Carl Zeiss Suzhou Co., Ltd.

The following data is part of a premarket notification filed by Carl Zeiss Suzhou Co., Ltd. with the FDA for Primus.

Pre-market Notification Details

• Device ID: K163195
• 510k Number: K163195
• Device Name: PRIMUS
• Classification: Tomography, Optical Coherence
• Applicant: Carl Zeiss Suzhou Co., Ltd. Modern Indust Rial Square 3b No. 333 Xing Pu Road Sip Suzhou, CN 215126
• Contact: Huang Xiaodong
• Correspondent: Dong Hua; Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568
• Product Code: OBO
• CFR Regulation Number: 886.1570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-11-15
• Decision Date: 2017-06-21
• Summary: summary