ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS

System, Measurement, Blood-pressure, Non-invasive

SANKEI CO., LTD.

The following data is part of a premarket notification filed by Sankei Co., Ltd. with the FDA for Aneroid Sphygmomanometers/mercurial Sphygmomanometersrs.

Pre-market Notification Details

• Device ID: K942543
• 510k Number: K942543
• Device Name: ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS
• Classification: System, Measurement, Blood-pressure, Non-invasive
• Applicant: SANKEI CO., LTD. 2126 BERWICK Inverness, IL 60067
• Contact: Bruce Shullo
• Correspondent: Bruce Shullo; SANKEI CO., LTD. 2126 BERWICK Inverness, IL 60067
• Product Code: DXN
• CFR Regulation Number: 870.1130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-04-25
• Decision Date: 1995-07-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10810132041621	K942543	000
10810132040884	K942543	000
10767056100111	K942543	000
10767056100159	K942543	000
10767056100166	K942543	000
10767056110219	K942543	000
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10767056232010	K942543	000
10767056234014	K942543	000
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10767056300153	K942543	000
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10767056330112	K942543	000
10767056330150	K942543	000
10767056330167	K942543	000
10810132040877	K942543	000
10810132040860	K942543	000
10810132041034	K942543	000
10810132041638	K942543	000
10810132041645	K942543	000
10810132041652	K942543	000
10810132041669	K942543	000
10810132041676	K942543	000
10810132041683	K942543	000
10810132041690	K942543	000
10810132041706	K942543	000
10810132041713	K942543	000
10810132041720	K942543	000
10810132041737	K942543	000
10810132041744	K942543	000
10810132041751	K942543	000
10810132041003	K942543	000
10810132041010	K942543	000
10810132041027	K942543	000
10767056400112	K942543	000
10767056400136	K942543	000
10849027000092	K942543	000
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10849027000542	K942543	000
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10849027000573	K942543	000
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10849027000597	K942543	000
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10767056400150	K942543	000
10767056400167	K942543	000
10767056400174	K942543	000
10767056600116	K942543	000
10767056601519	K942543	000
10767056601618	K942543	000
10767056690117	K942543	000
10767056690162	K942543	000
10767056740119	K942543	000
10767056830216	K942543	000
10767056830230	K942543	000
10849027000016	K942543	000
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10849027000030	K942543	000
10849027000047	K942543	000
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10849027002874	K942543	000