510k
Database
Specialties
Anesthesiology
508
Cardiovascular
1581
Chemistry
355
Dental
1270
Ear, Nose, Throat
233
Gastroenterology & Urology
920
General & Plastic Surgery
2106
General Hospital
1837
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
924
Obstetrics & Gynecology
419
Ophthalmic
265
Orthopedic
2677
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49
Physical Medicine
506
Radiology
2289
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
377
LLZ
System, Image Processing,...
356
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
292
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
260
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Respironics Novametrix, LLC
Medical Device Manufacturer
·
US , Wallingford , CT
Respironics Novametrix, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2006
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Respironics Novametrix, LLC
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 02, 2011
PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST
K103578
·
BZK
Anesthesiology
·
178d
Cleared
Jul 28, 2009
PHILIPS NM3 MONITOR, MODEL 7900
K091459
·
BZK
Anesthesiology
·
71d
Cleared
Jun 20, 2008
MERCURY VCO2 MODULE WITH CAPNOSTAT 5
K080652
·
BZK
Anesthesiology
·
105d
Cleared
Jan 12, 2006
LOFLO C5 CO2 SENSOR
K053174
·
CCK
Anesthesiology
·
59d
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4
Anesthesiology
4