FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
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
BRX
Stool, Anesthesia
1
Product Code
BRY
Cabinet, Table And Tray, Anesthesia
1
Product Code
BSY
Catheters, Suction, Tracheobronchial
1
Product Code
BTI
Compressor, Air, Portable
2
Product Code
BXJ
Clip, Nose
1
Product Code
BXK
Gas, Calibration (Specified Concentration)
1
Product Code
K
95
4804
LUNG DIFFUSION MIXTURES
1
Cleared 510(K)
K
95
4803
BLOOD GAS MIXTURES
1
Cleared 510(K)
K
95
4542
LUNG DIFFUSION MIXTURE
1
Cleared 510(K)
K
95
2838
MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES
1
Cleared 510(K)
K
95
3934
MED-TECH LUNG DIFFUSION MIXTURE
1
Cleared 510(K)
K
95
3208
MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES
1
Cleared 510(K)
K
94
4998
CALIBRATION GAS
1
Cleared 510(K)
K
94
4812
CLINICAL BLOOD GAS MIXTURE
1
Cleared 510(K)
K
94
2866
CLINICAL BLOOD GAS MIXTURE
1
Cleared 510(K)
K
93
2874
BLOOD GAS MIXTURE
1
Cleared 510(K)
K
93
5311
CLINICAL BLOOD GAS
1
Cleared 510(K)
K
93
2520
CALIBRATION GAS
1
Cleared 510(K)
K
92
4796
LUNG DIFFUSION GAS MIXTURE
1
Cleared 510(K)
K
92
4795
BLOOD GAS MIXTURE
1
Cleared 510(K)
K
91
1264
CALIBRATION KIT
1
Cleared 510(K)
K
91
1471
LUNG DIFFUSION GAS MIXTURES
1
Cleared 510(K)
K
90
2754
ANESTHETIC GAS CALIBRATION MIXTURE
1
Cleared 510(K)
K
88
2210
MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES
1
Cleared 510(K)
K
87
3586
LUNG DIFFUSION GAS
1
Cleared 510(K)
K
87
4297
CALIBRATION GAS FOR CARBON DIOXIDE MONITOR
1
Cleared 510(K)
K
87
3587
BLOOD ANALYSIS GAS
1
Cleared 510(K)
K
87
1100
O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP
1
Cleared 510(K)
K
87
1101
0.1 TO 25.0% OXYGEN, USP, BALANCE NITROGEN, N.F.
1
Cleared 510(K)
K
87
1102
O.1 TO 50.0% CARBON DIOXIDE, USP BALANCE NITRO.,NF
1
Cleared 510(K)
K
87
1103
O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P
1
Cleared 510(K)
K
87
0139
GAS, CALIBRATION, SPECIFIED CONCENTRATION
1
Cleared 510(K)
K
86
3675
CALIBRATION GAS FOR SERVO GAS MONITOR 120
1
Cleared 510(K)
K
82
2764
LUNG DIFFUSION MIXTURE
1
Cleared 510(K)
K
82
2763
CLINICAL GAS MIXTURE-NON-FLAMMABLE
1
Cleared 510(K)
K
82
2762
CLINICAL GAS MIXTURE-FLAMMABLE
1
Cleared 510(K)
K
82
2752
ANAEROBIC CARBON DIOXIDE
1
Cleared 510(K)
K
82
2753
BLOOD GAS MIXTURE
1
Cleared 510(K)
BZN
Cart, Emergency, Cardiopulmonary (Excluding Equipment)
1
Product Code
CAM
Yoke Assembly, Medical Gas
1
Product Code
CCX
Support, Patient Position
1
Product Code
OFO
Airway Suction Kit
1
Product Code
OFR
Tracheobronchial Suction Catheter Kit
1
Product Code
OFS
Tracheal Suction Set
1
Product Code
OYI
Non-Bronchoscopic Bronchoalveolar Lavage Catheter
1
Product Code
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-g—miscellaneous
/
BXK
/
K863675
View Source
CALIBRATION GAS FOR SERVO GAS MONITOR 120
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K863675
510(k) Type
Traditional
Applicant
SIEMENS ELEMA AB
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/3/1986
Days to Decision
45 days
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
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
BRX
Stool, Anesthesia
BRY
Cabinet, Table And Tray, Anesthesia
BSY
Catheters, Suction, Tracheobronchial
BTI
Compressor, Air, Portable
BXJ
Clip, Nose
BXK
Gas, Calibration (Specified Concentration)
K
95
4804
LUNG DIFFUSION MIXTURES
K
95
4803
BLOOD GAS MIXTURES
K
95
4542
LUNG DIFFUSION MIXTURE
K
95
2838
MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES
K
95
3934
MED-TECH LUNG DIFFUSION MIXTURE
K
95
3208
MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES
K
94
4998
CALIBRATION GAS
K
94
4812
CLINICAL BLOOD GAS MIXTURE
K
94
2866
CLINICAL BLOOD GAS MIXTURE
K
93
2874
BLOOD GAS MIXTURE
K
93
5311
CLINICAL BLOOD GAS
K
93
2520
CALIBRATION GAS
K
92
4796
LUNG DIFFUSION GAS MIXTURE
K
92
4795
BLOOD GAS MIXTURE
K
91
1264
CALIBRATION KIT
K
91
1471
LUNG DIFFUSION GAS MIXTURES
K
90
2754
ANESTHETIC GAS CALIBRATION MIXTURE
K
88
2210
MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES
K
87
3586
LUNG DIFFUSION GAS
K
87
4297
CALIBRATION GAS FOR CARBON DIOXIDE MONITOR
K
87
3587
BLOOD ANALYSIS GAS
K
87
1100
O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP
K
87
1101
0.1 TO 25.0% OXYGEN, USP, BALANCE NITROGEN, N.F.
K
87
1102
O.1 TO 50.0% CARBON DIOXIDE, USP BALANCE NITRO.,NF
K
87
1103
O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P
K
87
0139
GAS, CALIBRATION, SPECIFIED CONCENTRATION
K
86
3675
CALIBRATION GAS FOR SERVO GAS MONITOR 120
K
82
2764
LUNG DIFFUSION MIXTURE
K
82
2763
CLINICAL GAS MIXTURE-NON-FLAMMABLE
K
82
2762
CLINICAL GAS MIXTURE-FLAMMABLE
K
82
2752
ANAEROBIC CARBON DIOXIDE
K
82
2753
BLOOD GAS MIXTURE
BZN
Cart, Emergency, Cardiopulmonary (Excluding Equipment)
CAM
Yoke Assembly, Medical Gas
CCX
Support, Patient Position
OFO
Airway Suction Kit
OFR
Tracheobronchial Suction Catheter Kit
OFS
Tracheal Suction Set
OYI
Non-Bronchoscopic Bronchoalveolar Lavage Catheter
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-g—miscellaneous
/
BXK
/
K863675
View Source
CALIBRATION GAS FOR SERVO GAS MONITOR 120
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K863675
510(k) Type
Traditional
Applicant
SIEMENS ELEMA AB
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/3/1986
Days to Decision
45 days