FDA Browser
by
Innolitics
Anesthesiology
Review Panel
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
Miscellaneous
Miscellaneous
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
MOC
Cushion, Flotation, Therapeutic
2
Product Code
IMG
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
2
Product Code
IMI
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
2
Product Code
IMJ
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
2
Product Code
QOL
Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
2
Product Code
QRA
Virtual Reality Behavioral Therapy Device For Pain Relief
2
Product Code
BXB
Exerciser, Powered
1
Product Code
EGJ
Device, Iontophoresis, Other Uses
2
Product Code
HPH
Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat
3
Product Code
IKW
Utensil, Homemaking
1
Product Code
IKX
Aid, Transfer
1
Product Code
IKZ
Bed, Patient Rotation, Powered
2
Product Code
ILC
Utensil, Eating
1
Product Code
ILD
Adaptor, Dressing
1
Product Code
ILJ
Bath, Hydro-Massage
2
Product Code
K
11
0994
PARKER 500
2
Cleared 510(K)
K
08
2951
IMMERSION HYDROBATH
2
Cleared 510(K)
K
05
2479
MBATH 1000 (60)
2
Cleared 510(K)
K
04
0772
PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
2
Cleared 510(K)
K
01
2057
CASCADE BATH, MODEL 6900
2
Cleared 510(K)
K
01
2061
SUPERIOR BATH, MODEL 6300
2
Cleared 510(K)
K
00
1079
RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
2
Cleared 510(K)
K
99
3872
VANNA BATHING SYSTEM
2
Cleared 510(K)
K
99
2779
A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM
2
Cleared 510(K)
K
99
1184
HYDROTONE-THERMAL CAPSULE SYSTEM
2
Cleared 510(K)
K
98
0909
VICHY SHOWER
2
Cleared 510(K)
K
98
0920
EQUINOXE
2
Cleared 510(K)
K
97
4321
HYDROTONE
2
Cleared 510(K)
K
98
0033
FERNO HEALTHCARE RECLINE-A-BATH 2
2
Cleared 510(K)
K
98
0769
WINDMERE MODEL DS-2 FOOT BATH
2
Cleared 510(K)
K
97
1592
XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM
2
Cleared 510(K)
K
97
1593
SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT
2
Cleared 510(K)
K
96
4926
BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC
2
Cleared 510(K)
K
95
2442
FREEDOM BATH
2
Cleared 510(K)
K
93
0665
CENTURY BATHING SYSTEM
2
Cleared 510(K)
K
93
0820
AQUADYNE
2
Cleared 510(K)
K
93
0821
THERA-FIT
2
Cleared 510(K)
K
92
5195
MALIBU BATHING SYSTEM
2
Cleared 510(K)
K
92
5193
AQUACISER II
2
Cleared 510(K)
K
93
0624
SANITAS WHIRPOOL BATHING SYSTEM
2
Cleared 510(K)
K
93
0096
NO CROSS CONTAM HYDROTHERAPY TANK LINER
2
Cleared 510(K)
K
92
3637
ARJO-CENTURY ARM AND LEG TANK SYSTEM
2
Cleared 510(K)
K
92
3617
FULL MOVEMENT THERAPY SYSTEMS
2
Cleared 510(K)
K
92
3159
ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS
2
Cleared 510(K)
K
92
2160
AQUAMOTION BY FERNO ILLE HYDROTHERAPY POOLS
2
Cleared 510(K)
K
91
4125
FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403
2
Cleared 510(K)
K
91
1758
AMISH COUNTRY SPA
2
Cleared 510(K)
K
91
1551
SHOWER MINI RD-7 SANITARY WASHER
2
Cleared 510(K)
K
90
5599
JETTA JR. HYDRO MASSAGE
2
Cleared 510(K)
K
91
0607
PACIFIC MARQUIS SPA
2
Cleared 510(K)
K
90
4106
SPA SHELL
2
Cleared 510(K)
K
90
2603
LIBERTY, FREEDOM & INDEPENDENCE IMMERS HYDRO BATH
2
Cleared 510(K)
K
89
0548
AQUACISER SYSTEM
2
Cleared 510(K)
K
89
0308
HYDROTONE I
2
Cleared 510(K)
K
88
3187
SCALP HYDROBATH/TREATMENT DELIVERY SYSTEM
2
Cleared 510(K)
K
88
3308
PARKER BATHING SYSTEM
2
Cleared 510(K)
K
88
0355
MODEL 938 BATHING SYSTEM
2
Cleared 510(K)
K
87
2327
WHIRLPOOL AERATOR WB700, WB800, WB900, WB975
2
Cleared 510(K)
K
86
4721
CRYOTHERM
2
Cleared 510(K)
K
86
1218
AQUA ARK, IMMERSION HYDROBATH
2
Cleared 510(K)
K
85
4861
SETMA HYGIA BATH MODEL ST 7200
2
Cleared 510(K)
K
85
4263
SETMA FHT, MODEL ST 8130
2
Cleared 510(K)
K
85
3163
SETMA VHT
2
Cleared 510(K)
K
84
4064
MEDO BUBBLE BATH MA-80, 400, 600 & 700
2
Cleared 510(K)
K
84
2941
MULTIPLE PLANETAMED;PLANETA HYDROMASS
2
Cleared 510(K)
K
84
2641
HYDRO/BUBBLE BATH DEVICE 300
2
Cleared 510(K)
K
84
2642
BALSAN 700
2
Cleared 510(K)
K
84
2643
MASSAPED
2
Cleared 510(K)
K
84
1954
OASIS CLUB HYDROMASSAGE
2
Cleared 510(K)
K
84
1397
BURN BATH
2
Cleared 510(K)
K
84
0282
OVERHEAD WHIRLPOOL HAND SPA BRAND
2
Cleared 510(K)
K
83
3839
BIOTHERM
2
Cleared 510(K)
K
82
1809
THERMOFONTE AIR MESSAGE BATH
2
Cleared 510(K)
K
81
2033
THE LYMAN BATHCHAIR
2
Cleared 510(K)
K
81
1904
CENTURY HYDRO-SAN THERAPY TANK
2
Cleared 510(K)
K
81
1903
CENTURY HYDROTHERAPY PUMP
2
Cleared 510(K)
K
81
0034
FOOT BATHS & HAND MASSAGERS
2
Cleared 510(K)
K
80
2335
WHIRLPOOL BATHING UNIT-#2001
2
Cleared 510(K)
K
79
2641
HYDRO PULSE MASSAGE
2
Cleared 510(K)
K
79
1718
SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL
2
Cleared 510(K)
K
79
1603
GILLETTE CORDLESS WHIRLPOOL
2
Cleared 510(K)
K
77
1966
VIBRO BATH MODEL FS-1
2
Cleared 510(K)
K
77
1970
WHIRLPOOL BATH MODEL 50
2
Cleared 510(K)
K
77
1969
TURBO-JET MODEL 76
2
Cleared 510(K)
K
77
1965
WHIRLPOOL BATH MODEL 2274
2
Cleared 510(K)
K
77
1968
WHIRLPOOL BATH MODEL 2273
2
Cleared 510(K)
K
77
1967
WHIRLPOOL BATH MODEL 2270
2
Cleared 510(K)
K
77
1971
HYDROMASSAGE EQUIP. MODEL 1000
2
Cleared 510(K)
ILK
Transport, Patient, Powered
2
Product Code
ILM
Bath, Sitz, Powered
2
Product Code
ILO
Pack, Hot Or Cold, Water Circulating
2
Product Code
ILS
Adaptor, Hygiene
1
Product Code
ILT
Adaptor, Recreational
1
Product Code
ILW
Adaptor, Grooming
1
Product Code
ILX
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
2
Product Code
ILY
Lamp, Infrared, Therapeutic Heating
2
Product Code
ILZ
Accessories, Traction
1
Product Code
IMA
Pack, Heat, Moist
1
Product Code
IMB
Cabinet, Moist Steam
2
Product Code
IMC
Bath, Paraffin
2
Product Code
IMD
Pack, Hot Or Cold, Disposable
1
Product Code
IME
Pack, Hot Or Cold, Reusable
1
Product Code
IMF
Unit, Chilling
1
Product Code
INX
Bed, Air Fluidized
2
Product Code
INY
Bed, Patient Rotation, Manual
1
Product Code
IOA
Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat
2
Product Code
IOB
Lamp, Infrared, Non Heating
2
Product Code
IOD
Components, Exercise
1
Product Code
IOE
Bars, Parallel, Exercise
1
Product Code
IOG
Treadmill, Mechanical
1
Product Code
IOL
Treadmill, Powered
1
Product Code
ION
Exerciser, Non-Measuring
1
Product Code
IOQ
Bed, Flotation Therapy, Powered
2
Product Code
IPF
Stimulator, Muscle, Powered
2
Product Code
IRN
Device, Warning, Overload, External Limb, Powered
2
Product Code
IRO
Vibrator, Therapeutic
1
Product Code
IRP
Massager, Powered Inflatable Tube
2
Product Code
IRQ
Unit, Heating, Powered
1
Product Code
IRR
Bars, Parallel, Powered
1
Product Code
IRS
Head Halter, Traction
1
Product Code
IRT
Pad, Heating, Powered
2
Product Code
ISA
Massager, Therapeutic, Electric
1
Product Code
ISD
Exerciser, Measuring
2
Product Code
ITH
Equipment, Traction, Powered
2
Product Code
JFA
Exerciser, Finger, Powered
1
Product Code
JFB
Table, Physical Therapy, Multi Function
2
Product Code
KNL
Board, Scooter, Prone
1
Product Code
KNM
Device, Pressure Applying
1
Product Code
KTB
Device, Iontophoresis, Specific Uses
2
Product Code
KTC
Bath, Sitz, Nonpowered
1
Product Code
LBG
Device, Fluidized Therapy, Dry Heat
2
Product Code
LSB
Unit, Fluidotherapy
2
Product Code
LXF
Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
3
Product Code
LXJ
Interactive Rehabilitation Exercise Devices
2
Product Code
LYG
Massager, Therapeutic, Manual
1
Product Code
MPO
Infant Heel Warmer (Chemical Heat Pack)
1
Product Code
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
2
Product Code
NHN
Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
2
Product Code
NYY
Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation
2
Product Code
NYZ
Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning
2
Product Code
OMW
Adhesive Backed Thermal Skin Patches
1
Product Code
OSD
Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
2
Product Code
PCD
Powered Stairway Chair Lift
2
Product Code
PFW
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
2
Product Code
PHW
Cold Pack And Vibrating Massager
1
Product Code
PKS
Exerciser, Non-Measuring For Stroke Rehabilitation
1
Product Code
PQY
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
2
Product Code
QKC
Interactive Rehabilitation Exercise Device, Prescription Use
2
Product Code
QKD
Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use
2
Product Code
QTC
Adult Portable Bed Rails For Medical Purposes
1
Product Code
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 9 May 2025 at 11:05 pm
PM
/
subpart-f—physical-medicine-therapeutic-devices
/
ILJ
/
K923159
View Source
ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K923159
510(k) Type
Traditional
Applicant
ARJO-CENTURY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/6/1992
Days to Decision
38 days
Submission Type
Statement
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
Miscellaneous
Subpart B—Physical Medicine Diagnostic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
MOC
Cushion, Flotation, Therapeutic
IMG
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
IMI
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
IMJ
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
QOL
Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
QRA
Virtual Reality Behavioral Therapy Device For Pain Relief
BXB
Exerciser, Powered
EGJ
Device, Iontophoresis, Other Uses
HPH
Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat
IKW
Utensil, Homemaking
IKX
Aid, Transfer
IKZ
Bed, Patient Rotation, Powered
ILC
Utensil, Eating
ILD
Adaptor, Dressing
ILJ
Bath, Hydro-Massage
K
11
0994
PARKER 500
K
08
2951
IMMERSION HYDROBATH
K
05
2479
MBATH 1000 (60)
K
04
0772
PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
K
01
2057
CASCADE BATH, MODEL 6900
K
01
2061
SUPERIOR BATH, MODEL 6300
K
00
1079
RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
K
99
3872
VANNA BATHING SYSTEM
K
99
2779
A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM
K
99
1184
HYDROTONE-THERMAL CAPSULE SYSTEM
K
98
0909
VICHY SHOWER
K
98
0920
EQUINOXE
K
97
4321
HYDROTONE
K
98
0033
FERNO HEALTHCARE RECLINE-A-BATH 2
K
98
0769
WINDMERE MODEL DS-2 FOOT BATH
K
97
1592
XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM
K
97
1593
SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT
K
96
4926
BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC
K
95
2442
FREEDOM BATH
K
93
0665
CENTURY BATHING SYSTEM
K
93
0820
AQUADYNE
K
93
0821
THERA-FIT
K
92
5195
MALIBU BATHING SYSTEM
K
92
5193
AQUACISER II
K
93
0624
SANITAS WHIRPOOL BATHING SYSTEM
K
93
0096
NO CROSS CONTAM HYDROTHERAPY TANK LINER
K
92
3637
ARJO-CENTURY ARM AND LEG TANK SYSTEM
K
92
3617
FULL MOVEMENT THERAPY SYSTEMS
K
92
3159
ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS
K
92
2160
AQUAMOTION BY FERNO ILLE HYDROTHERAPY POOLS
K
91
4125
FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403
K
91
1758
AMISH COUNTRY SPA
K
91
1551
SHOWER MINI RD-7 SANITARY WASHER
K
90
5599
JETTA JR. HYDRO MASSAGE
K
91
0607
PACIFIC MARQUIS SPA
K
90
4106
SPA SHELL
K
90
2603
LIBERTY, FREEDOM & INDEPENDENCE IMMERS HYDRO BATH
K
89
0548
AQUACISER SYSTEM
K
89
0308
HYDROTONE I
K
88
3187
SCALP HYDROBATH/TREATMENT DELIVERY SYSTEM
K
88
3308
PARKER BATHING SYSTEM
K
88
0355
MODEL 938 BATHING SYSTEM
K
87
2327
WHIRLPOOL AERATOR WB700, WB800, WB900, WB975
K
86
4721
CRYOTHERM
K
86
1218
AQUA ARK, IMMERSION HYDROBATH
K
85
4861
SETMA HYGIA BATH MODEL ST 7200
K
85
4263
SETMA FHT, MODEL ST 8130
K
85
3163
SETMA VHT
K
84
4064
MEDO BUBBLE BATH MA-80, 400, 600 & 700
K
84
2941
MULTIPLE PLANETAMED;PLANETA HYDROMASS
K
84
2641
HYDRO/BUBBLE BATH DEVICE 300
K
84
2642
BALSAN 700
K
84
2643
MASSAPED
K
84
1954
OASIS CLUB HYDROMASSAGE
K
84
1397
BURN BATH
K
84
0282
OVERHEAD WHIRLPOOL HAND SPA BRAND
K
83
3839
BIOTHERM
K
82
1809
THERMOFONTE AIR MESSAGE BATH
K
81
2033
THE LYMAN BATHCHAIR
K
81
1904
CENTURY HYDRO-SAN THERAPY TANK
K
81
1903
CENTURY HYDROTHERAPY PUMP
K
81
0034
FOOT BATHS & HAND MASSAGERS
K
80
2335
WHIRLPOOL BATHING UNIT-#2001
K
79
2641
HYDRO PULSE MASSAGE
K
79
1718
SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL
K
79
1603
GILLETTE CORDLESS WHIRLPOOL
K
77
1966
VIBRO BATH MODEL FS-1
K
77
1970
WHIRLPOOL BATH MODEL 50
K
77
1969
TURBO-JET MODEL 76
K
77
1965
WHIRLPOOL BATH MODEL 2274
K
77
1968
WHIRLPOOL BATH MODEL 2273
K
77
1967
WHIRLPOOL BATH MODEL 2270
K
77
1971
HYDROMASSAGE EQUIP. MODEL 1000
ILK
Transport, Patient, Powered
ILM
Bath, Sitz, Powered
ILO
Pack, Hot Or Cold, Water Circulating
ILS
Adaptor, Hygiene
ILT
Adaptor, Recreational
ILW
Adaptor, Grooming
ILX
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
ILY
Lamp, Infrared, Therapeutic Heating
ILZ
Accessories, Traction
IMA
Pack, Heat, Moist
IMB
Cabinet, Moist Steam
IMC
Bath, Paraffin
IMD
Pack, Hot Or Cold, Disposable
IME
Pack, Hot Or Cold, Reusable
IMF
Unit, Chilling
INX
Bed, Air Fluidized
INY
Bed, Patient Rotation, Manual
IOA
Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat
IOB
Lamp, Infrared, Non Heating
IOD
Components, Exercise
IOE
Bars, Parallel, Exercise
IOG
Treadmill, Mechanical
IOL
Treadmill, Powered
ION
Exerciser, Non-Measuring
IOQ
Bed, Flotation Therapy, Powered
IPF
Stimulator, Muscle, Powered
IRN
Device, Warning, Overload, External Limb, Powered
IRO
Vibrator, Therapeutic
IRP
Massager, Powered Inflatable Tube
IRQ
Unit, Heating, Powered
IRR
Bars, Parallel, Powered
IRS
Head Halter, Traction
IRT
Pad, Heating, Powered
ISA
Massager, Therapeutic, Electric
ISD
Exerciser, Measuring
ITH
Equipment, Traction, Powered
JFA
Exerciser, Finger, Powered
JFB
Table, Physical Therapy, Multi Function
KNL
Board, Scooter, Prone
KNM
Device, Pressure Applying
KTB
Device, Iontophoresis, Specific Uses
KTC
Bath, Sitz, Nonpowered
LBG
Device, Fluidized Therapy, Dry Heat
LSB
Unit, Fluidotherapy
LXF
Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
LXJ
Interactive Rehabilitation Exercise Devices
LYG
Massager, Therapeutic, Manual
MPO
Infant Heel Warmer (Chemical Heat Pack)
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
NHN
Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
NYY
Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation
NYZ
Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning
OMW
Adhesive Backed Thermal Skin Patches
OSD
Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
PCD
Powered Stairway Chair Lift
PFW
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
PHW
Cold Pack And Vibrating Massager
PKS
Exerciser, Non-Measuring For Stroke Rehabilitation
PQY
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
QKC
Interactive Rehabilitation Exercise Device, Prescription Use
QKD
Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use
QTC
Adult Portable Bed Rails For Medical Purposes
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
PM
/
subpart-f—physical-medicine-therapeutic-devices
/
ILJ
/
K923159
View Source
ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K923159
510(k) Type
Traditional
Applicant
ARJO-CENTURY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/6/1992
Days to Decision
38 days
Submission Type
Statement