Identity
- Trade Name
- BresoDX1 BresoSensor FDA UDI
- Generic Name
- Home-use sleep apnoea recording system FDA UDI
- Device Name
- BresoSensor is a component of BresoDX1. During a test, BresoSensor is placed on the suprasternal notch of a patient and collects the tracheal sound and tracheo-sternal motion through a microphone and three-dimensional accelerometer. The BresoSensor is powered by an internal Lithium-ion rechargeable battery. It is only sold in USA. FDA UDI
- Model / Reference
- BTSM1US-URU FDA UDI
- Description
- BresoSensor is a component of BresoDX1. During a test, BresoSensor is placed on the suprasternal notch of a patient and collects the tracheal sound and tracheo-sternal motion through a microphone and three-dimensional accelerometer. The BresoSensor is powered by an internal Lithium-ion rechargeable battery. It is only sold in USA. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00990008600022 FDA UDI
- 510(k) Number
- K220012 FDA UDI
- FDA Product Code
- MNR FDA UDI
- GMDN Term
- Home-use sleep apnoea recording system 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
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
No
FDA UDI
MR Unsafe FDA UDI
Category: Home-use sleep apnoea recording system
BresoDX1 BresoSensor by Bresotec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Bresotec, Inc.
Sources (1)
- FDA UDI 853ac0da-2e75-4a98-a9b2-1df35b7965dc 34 fields · synced May 30, 2026