510k
Database
Specialties
Anesthesiology
531
Cardiovascular
1642
Chemistry
359
Dental
1314
Ear, Nose, Throat
242
Gastroenterology & Urology
954
General & Plastic Surgery
2166
General Hospital
2031
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
951
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2819
Pathology
52
Physical Medicine
515
Radiology
2400
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
379
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
299
IYN
System, Imaging, Pulsed Doppler,...
283
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
208
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Spacelabs, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Spacelabs, Inc. - FDA 510(k) Cleared Devices
46 submissions
·
46 cleared
·
Since 1976
Official Website
46
Total
46
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spacelabs, Inc.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 20, 1992
ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE
K912742
·
FLL
General Hospital
·
304d
Cleared
Feb 13, 1984
MODEL 1888 ALPHA COS/RESPIRATION CAR
K834460
·
LLK
General Hospital
·
56d
Cleared
Dec 23, 1976
SERIES 700 PATIENT MONITORS
K761244
·
FLL
General Hospital
·
10d
Filters
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All
46
Cardiovascular
33
Anesthesiology
9
General Hospital
3
Neurology
1