OED · Class II · 21 CFR 870.1120

FDA Product Code OED: Antimicrobial Blood Pressure Cuff

Device Is A Replacement Cuff To Be Used In Conjunction With A Non-invasive Blood Pressure Monitor. Together The Devices Determine Blood Pressures And Heart Rate. This Particular Cuff Contains An Embedded Antimicrobial. A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve(cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.

Leading manufacturers include Philips Medical Systems and Statcorp Medical.

2
Total
2
Cleared
233d
Avg days
2007
Since

FDA 510(k) Cleared Antimicrobial Blood Pressure Cuff Devices (Product Code OED)

2 devices
1–2 of 2
Cleared Jun 04, 2013
ULTRACHECK CURVE BLOOD PRESSURE CUFFS
K122365
Statcorp Medical
Cardiovascular · 302d
Cleared Dec 20, 2007
ANTIMICROBIAL AND SINGLE-PATIENT CUFFS
K071885
Philips Medical Systems
Cardiovascular · 164d

About Product Code OED - Regulatory Context