510(k) K870728

TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701 by A&D Engineering, Inc. — Product Code DRQ

K870728 is an FDA 510(k) premarket notification submitted by A&D Engineering, Inc. for the device "TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701". The FDA issued a decision of Substantially Equivalent on March 27, 1987. The device falls under product code DRQ (Amplifier And Signal Conditioner, Transducer Signal), a Class II device regulated under 21 CFR 870.2060. A&D Engineering, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1987
Date Received
February 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier And Signal Conditioner, Transducer Signal
Device Class
Class II
Regulation Number
870.2060
Review Panel
CV
Submission Type