← Back to catalogue

Accessories for Endo PAT 2000

FDA UDI

Class II (US FDA UDI)

by Itamar Medical

Identity

Trade Name
Accessories for Endo PAT 2000 FDA UDI
Generic Name
Cardiovascular-risk peripheral arterial tonometry system FDA UDI
Device Name
Accessories, EndoPAT2000 FDA UDI
Model / Reference
Accessories for Endo PAT 2000 FDA UDI
Description
Accessories, EndoPAT2000 FDA UDI

Identifiers

Catalog Number
AC0001600 FDA UDI
Primary DI / UDI-DI
07290109225203 FDA UDI
510(k) Number
K032519 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Cardiovascular-risk peripheral arterial tonometry system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 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

No

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiovascular-risk peripheral arterial tonometry system

Accessories for Endo PAT 2000 by Itamar Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiovascular-risk peripheral arterial tonometry system.

Cleared under the same submission

K032519 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Itamar Medical

Sources (1)

  • FDA UDI e08dbaec-912a-44b2-9bfb-74a2ec164c02 37 fields · synced May 30, 2026