510k
Database
Specialties
Anesthesiology
550
Cardiovascular
1727
Chemistry
386
Dental
1394
Ear, Nose, Throat
256
Gastroenterology & Urology
992
General & Plastic Surgery
2235
General Hospital
2093
Hematology
127
Immunology
104
Medical Genetics
8
Microbiology
474
Neurology
985
Obstetrics & Gynecology
444
Ophthalmic
286
Orthopedic
3071
Pathology
52
Physical Medicine
515
Radiology
2508
Toxicology
156
Categories
LZA
Polymer Patient Examination Glove
418
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
366
FXX
Mask, Surgical
359
GEI
Electrosurgical, Cutting &...
310
IYN
System, Imaging, Pulsed Doppler,...
305
HRS
Plate, Fixation, Bone
299
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
234
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Fisher & Paykel Healthcare
Medical Device Manufacturer
·
NZ , Auckland
Fisher & Paykel Healthcare - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2017
Official Website
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fisher & Paykel Healthcare
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
May 08, 2024
F&P myAirvo 3
K222292
·
BTT
Anesthesiology
·
649d
Cleared
Jun 16, 2023
F&P 950 Respiratory Humidifier
K220703
·
BTT
Anesthesiology
·
463d
Cleared
Jan 27, 2023
F&P Airvo 3
K221338
·
QAV
Anesthesiology
·
263d
Cleared
Dec 20, 2018
AirSpiral Heated Breathing Tube
K162553
·
BTT
Anesthesiology
·
828d
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5
Anesthesiology
4
Obstetrics & Gynecology
1