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WIRELESS ECG includes PC based receiver, Trigger out and detachable lead set

FDA UDI

Class II (US FDA UDI)

by Norav Medical Inc.

Identity

Trade Name
WIRELESS ECG includes PC based receiver, Trigger out and detachable lead set FDA UDI
Generic Name
Electrocardiography telemetric monitoring system transmitter FDA UDI
Device Name
The PCECG 1200W System is comprised of wireless ECG recording box, which is based on an approved hardware, a RF receiver box connected to the computer and an ECG test software application. The intended user (patient) of the device is a subject that is referred to a rest (Stress) test for ischemic heart disease assessment ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value FDA UDI
Model / Reference
PCECG 1200W FDA UDI
Description
The PCECG 1200W System is comprised of wireless ECG recording box, which is based on an approved hardware, a RF receiver box connected to the computer and an ECG test software application. The intended user (patient) of the device is a subject that is referred to a rest (Stress) test for ischemic heart disease assessment ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value FDA UDI

Identifiers

Primary DI / UDI-DI
07290110250485 FDA UDI
FDA Product Code
MWI FDA UDI
GMDN Term
Electrocardiography telemetric monitoring system transmitter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrocardiography telemetric monitoring system transmitter

WIRELESS ECG includes PC based receiver, Trigger out and detachable lead set by Norav Medical Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Electrocardiography telemetric monitoring system transmitter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Norav Medical Inc.

Sources (1)

  • FDA UDI f56c5273-064e-48a9-940d-3ddb2ae4ecc9 34 fields · synced Jun 1, 2026