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Siesta

FDA UDI

Class II (US FDA UDI)

by Compumedics Usa, Inc.

Identity

Trade Name
Siesta FDA UDI
Generic Name
Polysomnograph FDA UDI
Device Name
Siesta 802 Basic PSG System w/o Software FDA UDI
Model / Reference
Siesta 802 Basic PSG System FDA UDI
Description
Siesta 802 Basic PSG System w/o Software FDA UDI

Identifiers

Catalog Number
9007-0060-00 FDA UDI
Primary DI / UDI-DI
09342451001788 FDA UDI
510(k) Number
K003175 FDA UDI
FDA Product Code
OLV FDA UDI
GWQ FDA UDI
GMDN Term
Polysomnograph FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1400 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Polysomnograph

Siesta by Compumedics Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polysomnograph.

Cleared under the same submission

K003175 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Compumedics Usa, Inc.

Sources (1)

  • FDA UDI 82771632-0f92-4f31-a98a-2dab8b1e38fb 35 fields · synced May 30, 2026