FDA.reportPublic FDA data

KLYO

Primary DI
B773KLTEM77
Brand
KLYO
Company
KLYO MEDICAL SYSTEMS INC.
Model
KL
Device description
Mobile, electro- motorized table designed to be adjusted to support a patient during many types of surgical interventions. The table surface consists of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions to satisfy the requirements of many clinical specialties.
Published
2023-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQOTable, Operating-Room, Ac-Powered
FWXTable, Operating-Room, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1
FWXTable, Operating-Room, MechanicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B773KLTEM77PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Universal operating table, electromechanicalA mobile, electrically-powered motorized table designed to be adjusted to support a patient during many types of surgical interventions. The table surface may consist of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions (e.g., the whole table top may be adjusted to form a curved surface), or designed to be used in conjunction with dedicated accessories (i.e., positioners, traction devices) to satisfy the requirements of many clinical specialties; it may have x-ray transparent features.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
305 330-5025sales@klyomedical.com

Regulatory Flags#

DUNS number
058639417
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B773KEHBD0KLYOKEHBD2024-02-23
B773KHSTR0KLYOKHSTR2024-02-23
B773KMHBD0KLYOKMHBD2024-02-23
B773KLEDL0KLYOKLED-L2024-02-22
B773KLEDS0KLYOKLED-S2024-02-22
B773KMOPT0KLYOKMOPT2024-02-22
B773KEOPT0KLYOKEOPT2024-02-21
B773KLEDM0KLYOKLED-M2019-07-11

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