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Innolitics
Anesthesiology
Review Panel
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Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
QLS
Pulse Oximeter For Low-Acuity Settings
2
Product Code
PGJ
Oximeter, Wellness
2
Product Code
DPZ
Oximeter, Ear
2
Product Code
K
04
2675
FLEXI-STAT SP02 EAR SENSOR
2
Cleared 510(K)
K
04
0831
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
2
Cleared 510(K)
K
01
2333
FLEXI-SITE SP02 EAR SENSOR
2
Cleared 510(K)
K
01
0718
FLEXI-SITE SP02 EAR SENSOR
2
Cleared 510(K)
K
94
4760
DURA-Y OXYGEN TRANSDUCER, EAR CLIP
2
Cleared 510(K)
K
94
2752
MARQUETTE EAR PROBE SENSOR
2
Cleared 510(K)
K
91
4595
PULSE RATE MONITOR
2
Cleared 510(K)
K
86
2426
PULSE OXIMETER
2
Cleared 510(K)
K
84
5051
VITALOG PMS-8
2
Cleared 510(K)
K
85
0494
OHMEDA BIOX 3700 PULSE OXIMETER
2
Cleared 510(K)
K
81
0363
EAR OXIMETER
2
Cleared 510(K)
DQA
Oximeter
2
Product Code
NLF
Oximeter, Reprocessed
2
Product Code
OLK
Pulse Oximeter For Over-The-Counter Use
2
Product Code
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
AN
/
subpart-c—cardiovascular-monitoring-devices
/
DPZ
/
K810363
View Source
EAR OXIMETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K810363
510(k) Type
Traditional
Applicant
BIO-TEK INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/27/1981
Days to Decision
16 days
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
QLS
Pulse Oximeter For Low-Acuity Settings
PGJ
Oximeter, Wellness
DPZ
Oximeter, Ear
K
04
2675
FLEXI-STAT SP02 EAR SENSOR
K
04
0831
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
K
01
2333
FLEXI-SITE SP02 EAR SENSOR
K
01
0718
FLEXI-SITE SP02 EAR SENSOR
K
94
4760
DURA-Y OXYGEN TRANSDUCER, EAR CLIP
K
94
2752
MARQUETTE EAR PROBE SENSOR
K
91
4595
PULSE RATE MONITOR
K
86
2426
PULSE OXIMETER
K
84
5051
VITALOG PMS-8
K
85
0494
OHMEDA BIOX 3700 PULSE OXIMETER
K
81
0363
EAR OXIMETER
DQA
Oximeter
NLF
Oximeter, Reprocessed
OLK
Pulse Oximeter For Over-The-Counter Use
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
AN
/
subpart-c—cardiovascular-monitoring-devices
/
DPZ
/
K810363
View Source
EAR OXIMETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K810363
510(k) Type
Traditional
Applicant
BIO-TEK INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/27/1981
Days to Decision
16 days