FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL

Oximeter

CONTEC MEDICAL SYSTEM CO., LTD.

The following data is part of a premarket notification filed by Contec Medical System Co., Ltd. with the FDA for Fingertip Pulse Oximeter, Models Cms-50d, Cms-50l, Cms-50dl.

Pre-market Notification Details

• Device ID: K082641
• 510k Number: K082641
• Device Name: FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL
• Classification: Oximeter
• Applicant: CONTEC MEDICAL SYSTEM CO., LTD. SUITE 8D , ZHONGXIN ZHONGSHAN MANSION, NO. 19, LANE 999, Zhong Shan, Shanghai, CN 20030
• Contact: Diana Hong
• Correspondent: Diana Hong; CONTEC MEDICAL SYSTEM CO., LTD. SUITE 8D , ZHONGXIN ZHONGSHAN MANSION, NO. 19, LANE 999, Zhong Shan, Shanghai, CN 20030
• Product Code: DQA
• CFR Regulation Number: 870.2700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-09-11
• Decision Date: 2008-11-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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