Microlife Manual Blood Pressure Monitor (Manual Inflate) Model BP-2BIO

FDA 510(k) K970139 · Micro Weiss Electronics

Substantially Equivalent

510(k) numberK970139

Submission

Device name
Microlife Manual Blood Pressure Monitor (Manual Inflate) Model BP-2BIO
Applicant
Micro Weiss Electronics
Great Neck,, NY, US
Received
January 15, 1997
Decision date
April 30, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DPW – Flowmeter, Blood, Cardiovascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2100
Specialty
Cardiovascular

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Questions and answers

When was Microlife Manual Blood Pressure Monitor (Manual Inflate) Model BP-2BIO cleared by the FDA?

Microlife Manual Blood Pressure Monitor (Manual Inflate) Model BP-2BIO (K970139) received a 510(k) decision of Substantially Equivalent on April 30, 1998, 470 days after the submission was received.

What is the product code of K970139?

The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.