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Anesthesiology
Review Panel
Cardiovascular
Review Panel
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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
K
18
0608
Lunoa System
2
Cleared 510(K)
K
14
0190
NIGHT SHIFT
2
Cleared 510(K)
K
10
0160
ZZOMA POSITIONAL SLEEPER MODEL 001
2
Cleared 510(K)
K
04
0161
SONA PILLOW
2
Cleared 510(K)
K
02
3010
SNIFF POSITION PILLOWS/POPITZ PILLOWS
2
Cleared 510(K)
K
99
0871
PILLOWPOSITIVE CERVICAL PILLOW
2
Cleared 510(K)
EPN
Pump, Nebulizer, Manual
1
Product Code
EPP
Splint, Nasal
1
Product Code
ETF
Unit, Examining/Treatment, Ent
1
Product Code
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 16 August 2024 at 11:05 pm
EN
/
subpart-f—therapeutic-devices
/
MYB
/
K180608
View Source
Lunoa System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180608
510(k) Type
Traditional
Applicant
NightBalance BV
Country
Netherlands
FDA Decision
Substantially Equivalent
Decision Date
6/5/2018
Days to Decision
90 days
Submission Type
Summary
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)
K
18
0608
Lunoa System
K
14
0190
NIGHT SHIFT
K
10
0160
ZZOMA POSITIONAL SLEEPER MODEL 001
K
04
0161
SONA PILLOW
K
02
3010
SNIFF POSITION PILLOWS/POPITZ PILLOWS
K
99
0871
PILLOWPOSITIVE CERVICAL PILLOW
EPN
Pump, Nebulizer, Manual
EPP
Splint, Nasal
ETF
Unit, Examining/Treatment, Ent
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
/
MYB
/
K180608
View Source
Lunoa System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180608
510(k) Type
Traditional
Applicant
NightBalance BV
Country
Netherlands
FDA Decision
Substantially Equivalent
Decision Date
6/5/2018
Days to Decision
90 days
Submission Type
Summary