WRIST BLOOD PRESSURE METER MODEL SE-330— 510(k) K973078

Name: FDA 510(k) clearance K973078
Creator: U.S. Food and Drug Administration
Published: 1999-05-20

Substantially Equivalent

Sein Electronics Co., Ltd.

FDA 510(k) clearance K973078 for WRIST BLOOD PRESSURE METER MODEL SE-330, Substantially Equivalent on 1999-05-20. Applicant: Sein Electronics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Sein Electronics Co., Ltd.
Product code: Product code DPW
Device class: Class 2
Regulation: 21 CFR 870.2100
Advisory panel: Cardiovascular
Date received: 1997-08-18
Decision date: 1999-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

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