510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1613
Chemistry
356
Dental
1304
Ear, Nose, Throat
237
Gastroenterology & Urology
934
General & Plastic Surgery
2142
General Hospital
2009
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
458
Neurology
942
Obstetrics & Gynecology
429
Ophthalmic
272
Orthopedic
2757
Pathology
52
Physical Medicine
515
Radiology
2354
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
406
LLZ
System, Image Processing,...
374
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
268
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Qrs Diagnostic, LLC
Medical Device Manufacturer
·
US , Plymouth , MN
Qrs Diagnostic, LLC - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 1998
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Qrs Diagnostic, LLC
Cardiovascular
✕
4
devices
1-4 of 4
Filters
Cleared
Mar 10, 2009
CARDIOVIEW32 REVIEW MODULE
K083749
·
LOS
Cardiovascular
·
83d
Cleared
Jan 11, 2008
MODIFICATION TO: BPCARD, MODEL Z-7000-0700
K073630
·
DXN
Cardiovascular
·
16d
Cleared
Sep 05, 2003
BPCARD
K031964
·
DXN
Cardiovascular
·
72d
Cleared
Jun 11, 2003
EKGCARD SYSTEM
K030535
·
DPS
Cardiovascular
·
111d
Filters
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7
Cardiovascular
4
Anesthesiology
3