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Cardea SOLO

FDA UDI

Class II (US FDA UDI)

by Cardiac Insight, Inc.

Identity

Trade Name
Cardea SOLO FDA UDI
Generic Name
Electrocardiographic ambulatory recorder FDA UDI
Device Name
Cardea SOLO Wearable Sensor (M300) FDA UDI
Model / Reference
M300-5 FDA UDI
Description
Cardea SOLO Wearable Sensor (M300) FDA UDI

Identifiers

Catalog Number
M300-5 FDA UDI
Primary DI / UDI-DI
10857553006112 FDA UDI
510(k) Number
K162503 FDA UDI
FDA Product Code
DQK FDA UDI
DSH FDA UDI
GMDN Term
Electrocardiographic ambulatory recorder FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 FDA UDI
870.2800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electrocardiographic ambulatory recorder

Cardea SOLO by Cardiac Insight, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic ambulatory recorder.

Cleared under the same submission

K162503 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardiac Insight, Inc.

Sources (1)

  • FDA UDI e9743a53-be40-4cc1-a912-9a5c2f05afd7 36 fields · synced May 30, 2026