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Natus

FDA UDI

Class II (US FDA UDI)

by Natus Neurology Incorporated

Identity

Trade Name
Natus FDA UDI
Generic Name
Electroencephalograph FDA UDI
Device Name
HB5 HEADBOX FOR V SERIES AMPLIFIERS FDA UDI
Model / Reference
515-006200 FDA UDI
Description
HB5 HEADBOX FOR V SERIES AMPLIFIERS FDA UDI

Identifiers

Primary DI / UDI-DI
00382830037815 FDA UDI
510(k) Number
K061908 FDA UDI
FDA Product Code
GWQ FDA UDI
GMDN Term
Electroencephalograph 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: Electroencephalograph

Natus by Natus Neurology Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electroencephalograph.

Cleared under the same submission

K061908 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Natus Neurology Incorporated

Sources (1)

  • FDA UDI 5ffbac39-22d4-4d13-953d-0ebadfe1df85 34 fields · synced Jun 9, 2026