Neko Health

Primary DI
07350170920220
Brand
Neko Health
Company
Neko Health AB
Model
Echo-2
Catalog number
102556
Device description
Optical module intended to capture motion-vibration signals from a laser-illuminated skin surface, synchronised with the heart cycle, to assess physiological information including heart rate and events in the cardiac cycle. Indicated for use by healthcare professionals for adult individuals without acute or critical hemodynamic conditions, in a professional healthcare setting.
Published
2026-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QOKHardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QOKHardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory RateCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K254240000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254240000Echo-2Neko Health AB2026-09-22QOK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350170920220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350170920220073501709202207350170920220

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, multifunctionA small unit dedicated to the measurement and displays of several physiological parameters, e.g., electrical activity of the heart, respiratory rate, temperature, blood pressure, pulse, and oximetry. The signals are obtained through connected cables/leads/probes. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer displaying the various parameters/information measured and provided by this module.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+46850242776support@nekohealth.com

Regulatory Flags#

DUNS number
353319894
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false