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SleepmateAC Body Position Sensor

FDA UDI

Class II (US FDA UDI)

by Ambu A/S

Identity

Trade Name
SleepmateAC Body Position Sensor FDA UDI
Generic Name
Polysomnograph FDA UDI
Device Name
Body Position AC Sensor FDA UDI
Model / Reference
815600-000 FDA UDI
Description
Body Position AC Sensor FDA UDI

Identifiers

Catalog Number
815600-000 FDA UDI
Primary DI / UDI-DI
05707480042555 FDA UDI
510(k) Number
K923033 FDA UDI
FDA Product Code
LXJ FDA UDI
GMDN Term
Polysomnograph FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5360 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Polysomnograph

SleepmateAC Body Position Sensor by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polysomnograph.

Cleared under the same submission

K923033 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ambu A/S

Sources (1)

  • FDA UDI abb4d4c0-da33-49b2-be35-b1315902897c 36 fields · synced May 30, 2026