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SleepmatePiezo Limb Sensor - Replacement

FDA UDI

Class II (US FDA UDI)

by Ambu A/S

Identity

Trade Name
SleepmatePiezo Limb Sensor - Replacement FDA UDI
Generic Name
Polysomnograph FDA UDI
Device Name
Ref. 1770 FDA UDI
Model / Reference
817230-100 FDA UDI
Description
Ref. 1770 FDA UDI

Identifiers

Catalog Number
817230-100 FDA UDI
Primary DI / UDI-DI
05707480042890 FDA UDI
510(k) Number
K935518 FDA UDI
FDA Product Code
BZQ FDA UDI
GMDN Term
Polysomnograph FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2375 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

SleepmatePiezo Limb Sensor - Replacement 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

K935518 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 794b2747-7ced-4a67-ab5c-14f37a8d8794 36 fields · synced May 30, 2026