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Spacelabs

FDA UDI

Class II (US FDA UDI)

by Spacelabs Healthcare (washington), Inc

Identity

Trade Name
Spacelabs FDA UDI
Generic Name
Patient monitoring system module, electroencephalographic FDA UDI
Device Name
MODULE,EEG/EMG,32MB FDA UDI
Model / Reference
MODULE,EEG/EMG FDA UDI
Description
MODULE,EEG/EMG,32MB FDA UDI

Identifiers

Catalog Number
N/A FDA UDI
Primary DI / UDI-DI
10841522106279 FDA UDI
510(k) Number
K932842 FDA UDI
FDA Product Code
GWQ FDA UDI
GMDN Term
Patient monitoring system module, electroencephalographic 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: Patient monitoring system module, electroencephalographic

Spacelabs by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient monitoring system module, electroencephalographic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spacelabs Healthcare (washington), Inc

Sources (1)

  • FDA UDI ca5a41b9-6029-4fe3-ad33-b7c570f61805 36 fields · synced Jun 1, 2026