Identity
- Trade Name
- Cascade IOMAX Intraoperative Monitor FDA UDI
- Generic Name
- Neurophysiologic monitoring system FDA UDI
- Device Name
- IOMAX 32 Channel Amplifier FDA UDI
- Model / Reference
- 190309-200 FDA UDI
- Description
- IOMAX 32 Channel Amplifier FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840067102763 FDA UDI
- 510(k) Number
- K162199 FDA UDI
- FDA Product Code
- IKN FDA UDIGWQ FDA UDIGWJ FDA UDIGZO FDA UDIJXE FDA UDIDQA FDA UDIGWF FDA UDIGWE FDA UDIOLT FDA UDIETN FDA UDI
- GMDN Term
- Neurophysiologic monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1375 FDA UDI882.1400 FDA UDI882.1900 FDA UDI882.1540 FDA UDI882.1550 FDA UDI870.2700 FDA UDI882.1870 FDA UDI882.1890 FDA UDI874.1820 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
No
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
No
FDA UDI
Category: Neurophysiologic monitoring system
Cascade IOMAX Intraoperative Monitor by Cadwell Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162199 also covers:
- Cascade IOMAX — Cadwell Industries, Inc.
- Cascade IOMAX — Cadwell Industries, Inc.
- Cascade IOMAX — Cadwell Industries, Inc.
- Cascade IOMAX — Cadwell Industries, Inc.
- Cascade IOMAX Intraoperative Monitor — Cadwell Industries, Inc.
- Cascade IOMAX Intraoperative Monitor — Cadwell Industries, Inc.
- Cascade IOMAX Intraoperative Monitor — Cadwell Industries, Inc.
- Cascade IOMAX Intraoperative Monitor — Cadwell Industries, Inc.
- IOMAX Extender Pod — Cadwell Industries, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cadwell Industries, Inc.
Sources (1)
- FDA UDI 4f34586d-9064-4dc5-99ab-de4c1487b2c5 35 fields · synced Jun 9, 2026