Identity
- Trade Name
- Radius VSM FDA UDI
- Generic Name
- Electronic acoustic stethoscope FDA UDI
- Device Name
- Radius VSM RAS-45 Acoustic Respiration Sensor, Adult, 10/Box FDA UDI
- Model / Reference
- 4828 FDA UDI
- Description
- Radius VSM RAS-45 Acoustic Respiration Sensor, Adult, 10/Box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10843997006184 FDA UDI
- 510(k) Number
- K223498 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- GMDN Term
- Electronic acoustic stethoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Commercial Distribution
- 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
Category: Electronic acoustic stethoscope
Radius VSM by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electronic acoustic stethoscope.
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- Adscope® — American Diagnostic Corporation · Class II
- RNK Products — Rnk Products, Inc. · Class II
- Eko Core Electronic Stethoscope — Eko Devices, Inc. · Class II
Cleared under the same submission
K223498 also covers:
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
- Masimo Corporation
Sources (1)
- FDA UDI 1897ee7d-092b-410e-9878-98bf37a0ce9f 36 fields · synced Jun 8, 2026