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Innolitics
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Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
NGU
Balloon, Liver Tamponade
2
Product Code
EYR
Tourniquet, Gastro-Urology
1
Product Code
EXM
Truss, Umbilical
1
Product Code
EYN
Tray, Irrigation, Sterile
2
Product Code
FBQ
Trocar, Gastro-Urology
2
Product Code
FZG
Apparatus, Air Handling, Bench
2
Product Code
FZH
Apparatus, Air Handling, Room
2
Product Code
K
92
3233
CARDIO-PAK LAPAROTOMY PACK
2
Cleared 510(K)
K
87
5305
MODEL UCA / SPEC SYSTEM UCA
2
Cleared 510(K)
K
87
1901
ULTRAFLOW
2
Cleared 510(K)
K
77
0084
OPERATING ROOM VENTILATOR
2
Cleared 510(K)
FZI
Apparatus, Air Handling, Enclosure
2
Product Code
GAX
Tourniquet, Nonpneumatic
1
Product Code
KCW
Epilator, High Frequency, Needle-Type
1
Product Code
KCX
Epilator, High Frequency, Tweezer-Type
1
Product Code
KCY
Tourniquet, Pneumatic
1
Product Code
KPJ
Chamber, Oxygen, Topical, Extremity
2
Product Code
OJS
Tourniquet Kit
1
Product Code
OLI
Fat Reducing Low Level Laser
2
Product Code
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
2
Product Code
QGX
General Use Pneumatic Tourniquet
1
Product Code
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
SU
/
subpart-f—therapeutic-devices
/
FZH
/
K875305
View Source
MODEL UCA / SPEC SYSTEM UCA
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K875305
510(k) Type
Traditional
Applicant
SPEC SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/27/1988
Days to Decision
29 days
FDA Browser
by
Innolitics
Anesthesiology
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
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
NGU
Balloon, Liver Tamponade
EYR
Tourniquet, Gastro-Urology
EXM
Truss, Umbilical
EYN
Tray, Irrigation, Sterile
FBQ
Trocar, Gastro-Urology
FZG
Apparatus, Air Handling, Bench
FZH
Apparatus, Air Handling, Room
K
92
3233
CARDIO-PAK LAPAROTOMY PACK
K
87
5305
MODEL UCA / SPEC SYSTEM UCA
K
87
1901
ULTRAFLOW
K
77
0084
OPERATING ROOM VENTILATOR
FZI
Apparatus, Air Handling, Enclosure
GAX
Tourniquet, Nonpneumatic
KCW
Epilator, High Frequency, Needle-Type
KCX
Epilator, High Frequency, Tweezer-Type
KCY
Tourniquet, Pneumatic
KPJ
Chamber, Oxygen, Topical, Extremity
OJS
Tourniquet Kit
OLI
Fat Reducing Low Level Laser
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
QGX
General Use Pneumatic Tourniquet
Toxicology
Medical Genetics
Unknown
SU
/
subpart-f—therapeutic-devices
/
FZH
/
K875305
View Source
MODEL UCA / SPEC SYSTEM UCA
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K875305
510(k) Type
Traditional
Applicant
SPEC SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/27/1988
Days to Decision
29 days