510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OEDClass II

Antimicrobial Blood Pressure Cuff

21 CFR 870.1120 / Cardiovascular
FDA source (opens on fda.gov)

OED is the FDA product code for Antimicrobial Blood Pressure Cuff, a class II device type, regulated under 21 CFR 870.1120. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OED
Device name
Antimicrobial Blood Pressure Cuff
FDA definition
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.
Regulation
21 CFR 870.1120
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code OED

By decision year
2 clearances under product code OED with a decision year between 2007 and 2013, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OED by decision year
YearClearances
20071
20131

Applicants with the most clearances

Product code OED
Applicants holding the most 510(k) clearances under product code OED
ApplicantClearances
Philips North America LLC1
Statcorp Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code