FDA.reportPublic FDA data

510(k) K071231

Device
EDAC QUANTIFIER
Applicant
Luna Innovations, Inc.
510(k) number
K071231
Product code
KRL
Decision
Substantially Equivalent (SESE)
Decision date
2007-05-17
Date received
2007-05-03
Regulation
870.4205
Classification name
Detector, Bubble, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Y

Applicant Contact#

Contact
KRISTINE RICHARDSON
Address
3157 State St. Blacksburg VA US 24060 24060

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KRL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K103469STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05Sorin Group Deutschland GmbH2011-01-18
K090698CAPIOX BUBBLE TRAP WITH X-COATINGTerumo Cardiovascular Systems2009-06-08
K961364AUTOMATIC TUBING CLAMP SYSTEM (ATC)Rocky Mountain Research, Inc.1996-10-31
K961598ELS AUTOMATIC TUBING CLAMP SYSTEMRocky Mountain Research, Inc.1996-10-29
K940651SARNS ULTRASONIC AIR SENSOR3M Health Care, Sarns1994-05-24
K935977SARNS AIR DETECTION SYSTEM3M Health Care, Sarns1994-02-04
K925661STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULESorin Biomedica, Fiat, USA, Inc.1993-05-18
K925541STOCKERT 1/4 BUBBLE SENSORSorin Biomedica, Fiat, USA, Inc.1993-02-02
K911632CAPIOX(R) BUBBLE TRAPTerumo Medical Corp.1991-07-09
K864619CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITORShiley, Inc.1987-02-03
K861860COBE ACCESSORY INTERFACE MODULE (AIM)Cobe Laboratories, Inc.1986-07-18
K842054COBE AEPSCobe Laboratories, Inc.1984-08-02
K803102ARTERIAL BUBBLE TRAP K-20Delta Medical Industries1980-12-22