Identity
- Trade Name
- Synergy E FDA UDI
- Generic Name
- Infant apnoea monitor FDA UDI
- Device Name
- Synergy E Host Software for SmartMonitor 2 Product Line FDA UDI
- Model / Reference
- 101483 FDA UDI
- Description
- Synergy E Host Software for SmartMonitor 2 Product Line FDA UDI
Identifiers
- Catalog Number
- 101483 FDA UDI
- Primary DI / UDI-DI
- B036101483 FDA UDI
- 510(k) Number
- K982550 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- GMDN Term
- Infant apnoea monitor 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Infant apnoea monitor
Synergy E by Circadiance — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infant apnoea monitor.
- SmartMonitor 2PS w/ Modem — Circadiance · Class II
- SmartMonitor 2PS Hospital Alarm — Circadiance · Class II
- SmartMonitor 2PSL w/o Modem — Circadiance · Class II
- SmartMonitor 2 w/ Modem — Circadiance · Class II
- SmartMonitor 2PSL w/ Modem — Circadiance · Class II
- SmartMonitor 2 w/o Modem — Circadiance · Class II
- SmartMonitor 2PSL Hospital Alarm w/o Modem — Circadiance · Class II
- SmartMonitor 2PSL Hospital Alarm w/ Modem — Circadiance · Class II
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
- Circadiance
Sources (1)
- FDA UDI ab2cc1c2-3ad3-4766-b38c-526be95dbcbc 36 fields · synced Jun 9, 2026