510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1683
Chemistry
370
Dental
1341
Ear, Nose, Throat
249
Gastroenterology & Urology
978
General & Plastic Surgery
2198
General Hospital
2048
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
471
Neurology
966
Obstetrics & Gynecology
436
Ophthalmic
279
Orthopedic
2946
Pathology
52
Physical Medicine
515
Radiology
2453
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
390
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
306
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
279
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Multispiro, Inc.
Medical Device Manufacturer
·
US , Irvine , CA
Multispiro, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1992
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Multispiro, Inc.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 11, 1992
THE PEAK
K920390
·
BZH
Anesthesiology
·
225d
Cleared
Jul 02, 1992
MULTISPIRO-BREEZE
K913681
·
BZC
Anesthesiology
·
318d
Cleared
Jul 02, 1992
MULTISPIRO-SX
K915451
·
BZG
Anesthesiology
·
210d
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3
Anesthesiology
3