FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic 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—Therapeutic Devices
CFR Sub-Part
OGP
Cricothyrotomy Kit
2
Product Code
OGV
Tracheostomy Cleaning Tray
2
Product Code
OGW
Tracheostomy Kit
2
Product Code
MYB
Pillow, Cervical (For Mild Sleep Apnea)
2
Product Code
EPN
Pump, Nebulizer, Manual
1
Product Code
EPP
Splint, Nasal
1
Product Code
ETF
Unit, Examining/Treatment, Ent
1
Product Code
K
95
3457
JEDMED SPECTRUM ENT CABINET
1
Cleared 510(K)
K
94
5395
PREMIER MIRROR WARMER
1
Cleared 510(K)
K
93
2470
LANGGASSE 90
1
Cleared 510(K)
K
91
1901
MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE
1
Cleared 510(K)
K
91
0781
#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES
1
Cleared 510(K)
K
91
0243
MOBILE TREATMENT CART
1
Cleared 510(K)
K
89
6273
SYSTEMA ENT CABINET
1
Cleared 510(K)
K
89
6298
JEDMED S CHAIR
1
Cleared 510(K)
K
88
1958
JEDMED MAXIM ENT CABINET
1
Cleared 510(K)
K
86
0940
MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT
1
Cleared 510(K)
K
85
5021
LARYNGEAL MIRROR PRE-WARMER
1
Cleared 510(K)
K
84
3046
RELIANCE TREATMENT CABINET
1
Cleared 510(K)
K
83
3882
INSTRUMENT CABINET
1
Cleared 510(K)
K
82
3226
SN-100 DOCTOR'S ROUND
1
Cleared 510(K)
K
82
2252
ENT TREATMENT UNITS
1
Cleared 510(K)
K
82
2531
MULTIPLE, ENT CABINET #448
1
Cleared 510(K)
K
82
2530
MULTIPLE, ENT CHAIR #418
1
Cleared 510(K)
K
82
2016
NAGASHIMA SN-SP UNIT AND CHAIR
1
Cleared 510(K)
K
81
3490
VERSION OF A CLOSED-FLOW SYS. CALORIC
1
Cleared 510(K)
K
81
0148
ATMOSET
1
Cleared 510(K)
K
80
2712
ENTERMED ENTUNIT
1
Cleared 510(K)
K
80
1740
TREATMENT UNIT FOR DOCTOR'S ROUNDS
1
Cleared 510(K)
K
80
1742
NEW FINE MODEL ENT TREATMENT UNIT
1
Cleared 510(K)
K
80
1741
PRETTY MODEL ENT TREATMENT UNIT
1
Cleared 510(K)
K
80
1739
NOBLE MODEL DOUBLESIDED TREATMENT UNIT
1
Cleared 510(K)
K
80
1738
NOBLE MEDEL ENT TREATMENT UNIT
1
Cleared 510(K)
K
80
0756
DUNRICH TABLES
1
Cleared 510(K)
K
80
0526
SMR H-CHAIR
1
Cleared 510(K)
K
79
1934
ATMOS ENT TREATMENT SYSTEM SERVANT 3
1
Cleared 510(K)
K
79
1936
ATMOS ENT CABINET PRACTICA 2
1
Cleared 510(K)
K
79
1935
ATMOS ENT CABINET PRACTICA 3
1
Cleared 510(K)
K
78
2064
TABLE, EXAMINING-TWO EIGHTY
1
Cleared 510(K)
EWT
Device, Antichoke, Suction
3
Product Code
EWW
Device, Antichoke, Tongs
3
Product Code
JPW
Pump, Nebulizer, Electrically Powered
1
Product Code
KCJ
Applicator, Ent
1
Product Code
KCL
Blower, Powder, Ent
1
Product Code
KCM
Dropper, Ent
1
Product Code
KCN
Ear Wick
1
Product Code
KCO
Nasal Spray, Ent Delivery
1
Product Code
KCP
Syringe, Ent
1
Product Code
KMA
Irrigator, Powered Nasal
1
Product Code
KTH
Device, Anti-Stammering
1
Product Code
LRD
Applicator, Ent Drug
1
Product Code
PKA
External Upper Esophageal Sphincter (Ues) Compression Device
2
Product Code
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
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 20 December 2024 at 11:05 pm
EN
/
subpart-f—therapeutic-devices
/
ETF
/
K801740
View Source
TREATMENT UNIT FOR DOCTOR'S ROUNDS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K801740
510(k) Type
Traditional
Applicant
JEDMED INSTRUMENT CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/13/1980
Days to Decision
19 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Miscellaneous
Subpart B—Diagnostic 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—Therapeutic Devices
OGP
Cricothyrotomy Kit
OGV
Tracheostomy Cleaning Tray
OGW
Tracheostomy Kit
MYB
Pillow, Cervical (For Mild Sleep Apnea)
EPN
Pump, Nebulizer, Manual
EPP
Splint, Nasal
ETF
Unit, Examining/Treatment, Ent
K
95
3457
JEDMED SPECTRUM ENT CABINET
K
94
5395
PREMIER MIRROR WARMER
K
93
2470
LANGGASSE 90
K
91
1901
MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE
K
91
0781
#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES
K
91
0243
MOBILE TREATMENT CART
K
89
6273
SYSTEMA ENT CABINET
K
89
6298
JEDMED S CHAIR
K
88
1958
JEDMED MAXIM ENT CABINET
K
86
0940
MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT
K
85
5021
LARYNGEAL MIRROR PRE-WARMER
K
84
3046
RELIANCE TREATMENT CABINET
K
83
3882
INSTRUMENT CABINET
K
82
3226
SN-100 DOCTOR'S ROUND
K
82
2252
ENT TREATMENT UNITS
K
82
2531
MULTIPLE, ENT CABINET #448
K
82
2530
MULTIPLE, ENT CHAIR #418
K
82
2016
NAGASHIMA SN-SP UNIT AND CHAIR
K
81
3490
VERSION OF A CLOSED-FLOW SYS. CALORIC
K
81
0148
ATMOSET
K
80
2712
ENTERMED ENTUNIT
K
80
1740
TREATMENT UNIT FOR DOCTOR'S ROUNDS
K
80
1742
NEW FINE MODEL ENT TREATMENT UNIT
K
80
1741
PRETTY MODEL ENT TREATMENT UNIT
K
80
1739
NOBLE MODEL DOUBLESIDED TREATMENT UNIT
K
80
1738
NOBLE MEDEL ENT TREATMENT UNIT
K
80
0756
DUNRICH TABLES
K
80
0526
SMR H-CHAIR
K
79
1934
ATMOS ENT TREATMENT SYSTEM SERVANT 3
K
79
1936
ATMOS ENT CABINET PRACTICA 2
K
79
1935
ATMOS ENT CABINET PRACTICA 3
K
78
2064
TABLE, EXAMINING-TWO EIGHTY
EWT
Device, Antichoke, Suction
EWW
Device, Antichoke, Tongs
JPW
Pump, Nebulizer, Electrically Powered
KCJ
Applicator, Ent
KCL
Blower, Powder, Ent
KCM
Dropper, Ent
KCN
Ear Wick
KCO
Nasal Spray, Ent Delivery
KCP
Syringe, Ent
KMA
Irrigator, Powered Nasal
KTH
Device, Anti-Stammering
LRD
Applicator, Ent Drug
PKA
External Upper Esophageal Sphincter (Ues) Compression Device
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
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
EN
/
subpart-f—therapeutic-devices
/
ETF
/
K801740
View Source
TREATMENT UNIT FOR DOCTOR'S ROUNDS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K801740
510(k) Type
Traditional
Applicant
JEDMED INSTRUMENT CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/13/1980
Days to Decision
19 days