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Cadwell Guardian

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K230415Ref 199321-200Model Neuro AccessoryRef 199333-000Model IONMRef 190313-200Ref 190314-200Ref 199334-000-008Ref 199334-000-003Ref 190316-200Ref 190310-200

by Cadwell Industries, Inc.

Identity

Trade Name
Cadwell Guardian EUDAMEDFDA UDI
Generic Name
Neurophysiologic monitoring system FDA UDI
Device Name
Amplifier Pod Cable, 3 meter FDA UDI
Amplifier Pod Cable, 8 meter FDA UDI
Goggles 2m FDA UDI
Input Extender Pod, TCS FDA UDI
AVX Auditory and Visual Stimulator FDA UDI
Power Comm FDA UDI
SMX-32 Direct Cortical Mapping FDA UDI
ES-10 Electrical Stimulator FDA UDI
Model / Reference
199334-000-003 EUDAMEDFDA UDI
199334-000-008 EUDAMEDFDA UDI
199321-200 EUDAMEDFDA UDI
199333-000 EUDAMEDFDA UDI
190316-200 EUDAMEDFDA UDI
190310-200 EUDAMEDFDA UDI
190314-200 EUDAMEDFDA UDI
190313-200 EUDAMEDFDA UDI
Neuro Accessory EUDAMED
IONM EUDAMED
Description
Amplifier Pod Cable, 3 meter FDA UDI
Amplifier Pod Cable, 8 meter FDA UDI
Goggles 2m FDA UDI
Input Extender Pod, TCS FDA UDI
AVX Auditory and Visual Stimulator FDA UDI
Power Comm FDA UDI
SMX-32 Direct Cortical Mapping FDA UDI
ES-10 Electrical Stimulator FDA UDI

Identifiers

Primary DI / UDI-DI
00840067103630 EUDAMEDFDA UDI
00840067103555 EUDAMEDFDA UDI
00840067102992 EUDAMEDFDA UDI
00840067103524 EUDAMEDFDA UDI
00840067103609 EUDAMEDFDA UDI
00840067102879 EUDAMEDFDA UDI
00840067102916 EUDAMEDFDA UDI
00840067102909 EUDAMEDFDA UDI
Basic UDI-DI
08400671NeuroAccessoryQX EUDAMED
08400671IONMJH EUDAMED
510(k) Number
K230415 FDA 510(k)
FDA Product Code
GWF FDA 510(k)FDA UDI
GZO FDA UDI
GWE FDA UDI
IKN FDA UDI
ETN FDA UDI
GWJ FDA UDI
JXE FDA UDI
PDQ FDA UDI
OLT FDA UDI
GWQ FDA UDI
EMDN Code
Z121002 NERVOUS SYSTEM MONITORING SYSTEMS EUDAMED
GMDN Term
Neurophysiologic monitoring system FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 882.1870 FDA 510(k)
Regulation Number
882.1870 FDA 510(k)FDA UDI
882.1540 FDA UDI
882.1890 FDA UDI
890.1375 FDA UDI
874.1820 FDA UDI
882.1900 FDA UDI
882.1550 FDA UDI
882.1400 FDA UDI
Market of Registration
Belgium EUDAMED
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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 UDIFDA UDI

Serial Number

No

FDA UDIFDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Cadwell Guardian by Cadwell Industries, Inc. — Class II — MDR, FDA_510K — listed in FDA 510(k), FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cadwell Industries, Inc.

Sources (17)

  • FDA 510(k) K230415 24 fields · synced Oct 6, 2026
  • FDA UDI 473bd198-7a41-4e97-a95f-835b58efb125 34 fields · synced May 29, 2026
  • FDA UDI 8ada4289-f88a-45c7-89bf-d371178037a0 34 fields · synced May 30, 2026
  • FDA UDI a2588e7f-2bbe-475d-bc97-2df7556bb0db 34 fields · synced May 30, 2026
  • FDA UDI 9bfd57be-3417-4b2c-818e-6bde1b992673 34 fields · synced May 30, 2026
  • FDA UDI 1a7700dd-15b3-4341-99a0-a576759bb840 34 fields · synced May 30, 2026
  • FDA UDI fc21801c-4012-42e8-bdb6-3474817342d7 34 fields · synced May 30, 2026
  • FDA UDI 9f178243-c81f-40da-9771-e4fa3e216d74 34 fields · synced May 30, 2026
  • FDA UDI e8e902b5-f962-49a4-8d16-6a21a7f68354 34 fields · synced May 30, 2026
  • EUDAMED e46b5fe5-0bd3-4b6c-ab53-69a60342f09e 61 fields · synced Jun 20, 2026
  • EUDAMED f409cc0c-fd2c-4c3e-8cc1-f6dcaeeb79ff 61 fields · synced Jul 17, 2026
  • EUDAMED 052f6677-b6b8-4b2c-b272-f2b3c6d4731d 61 fields · synced Jul 17, 2026
  • EUDAMED cd7a2ea4-cb62-43ca-9dee-bac25ba4cf08 61 fields · synced Jul 18, 2026
  • EUDAMED 7a49f7ae-ffe4-4749-871c-303a9691e43f 61 fields · synced Jul 19, 2026
  • EUDAMED 2acf0ee0-0e04-47d7-a016-be285854f4f3 61 fields · synced Jul 26, 2026
  • EUDAMED 2102efec-320c-4ef2-852e-13c3c94bff57 61 fields · synced Jul 28, 2026
  • EUDAMED af47bad7-0a54-4d14-a962-edacd90ef7cd 61 fields · synced Jul 31, 2026