510k
Database
Specialties
Anesthesiology
529
Cardiovascular
1640
Chemistry
359
Dental
1312
Ear, Nose, Throat
239
Gastroenterology & Urology
950
General & Plastic Surgery
2164
General Hospital
2029
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
459
Neurology
950
Obstetrics & Gynecology
430
Ophthalmic
272
Orthopedic
2798
Pathology
52
Physical Medicine
515
Radiology
2375
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
377
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
IYN
System, Imaging, Pulsed Doppler,...
279
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
222
NHA
Abutment, Implant, Dental,...
205
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P.K. Morgan , Ltd.
Medical Device Manufacturer
·
GB , Kent Rainham Me8 7ed
P.K. Morgan , Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1996
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - P.K. Morgan , Ltd.
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 01, 1997
BENCHMARK TRANSFER TEST
K954730
·
BZC
Anesthesiology
·
533d
Cleared
Jan 09, 1997
AUTOLINK BODY PLETHYSMOGRAPH
K960121
·
BZC
Anesthesiology
·
364d
Cleared
Jan 06, 1997
OXYLOG 2
K954731
·
BZL
Anesthesiology
·
448d
Cleared
Dec 09, 1996
TRANSFLOW TEST
K953990
·
BZC
Anesthesiology
·
473d
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4
Anesthesiology
4