MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254

System, Measurement, Blood-pressure, Non-invasive

MATSUSHITA ELECTRIC CORP. OF AMERICA

The following data is part of a premarket notification filed by Matsushita Electric Corp. Of America with the FDA for Meca Wrist Blood Pressure Meter, Model Ew243 And Model Ew254.

Pre-market Notification Details

• Device ID: K991458
• 510k Number: K991458
• Device Name: MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254
• Classification: System, Measurement, Blood-pressure, Non-invasive
• Applicant: MATSUSHITA ELECTRIC CORP. OF AMERICA 1730 PENNSYLVANIA AVE., N.W. Washington, DC 20006 -4706
• Contact: Edward M Basile
• Correspondent: Edward M Basile; MATSUSHITA ELECTRIC CORP. OF AMERICA 1730 PENNSYLVANIA AVE., N.W. Washington, DC 20006 -4706
• Product Code: DXN
• CFR Regulation Number: 870.1130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-04-26
• Decision Date: 2000-04-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10851439007088	K991458	000
00851439007029	K991458	000