Identity
- Trade Name
- Stealth System S300 FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- Stealth System Wearable Sensor (M300). FDA UDI
- Model / Reference
- M300-5 FDA UDI
- Description
- Stealth System Wearable Sensor (M300). FDA UDI
Identifiers
- Catalog Number
- M300-5 FDA UDI
- Primary DI / UDI-DI
- 20857553006072 FDA UDI
- 510(k) Number
- K162503 FDA UDI
- FDA Product Code
- DQK FDA UDIDSH FDA UDI
- GMDN Term
- Electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1425 FDA UDI870.2800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Stealth System S300 by Cardiac Insight, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Cardiac Insight, Inc.
Sources (1)
- FDA UDI 03f9f8ab-c7c1-4b55-98dc-a948b01f3f69 37 fields · synced May 30, 2026