510(k) K970139

MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO by Micro Weiss Electronics — Product Code DPW

K970139 is an FDA 510(k) premarket notification submitted by Micro Weiss Electronics for the device "MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO". The FDA issued a decision of Substantially Equivalent on April 30, 1998. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Micro Weiss Electronics has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1998
Date Received
January 15, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type