Identity
- Trade Name
- Defibtech ACC Event Connect FDA UDI
- Generic Name
- Medical equipment clinical data interfacing software FDA UDI
- Model / Reference
- RAC-U1600 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815098020690 FDA UDI
- 510(k) Number
- K141809 FDA UDI
- FDA Product Code
- DRM FDA UDI
- GMDN Term
- Medical equipment clinical data interfacing software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5200 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical equipment clinical data interfacing software
Defibtech ACC Event Connect by Defibtech, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical equipment clinical data interfacing software.
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- Intesys Clinical Suite — SPACELABS HEALTHCARE (WASHINGTON), INC · Class I
- Care Orchestrator Denmark — Respironics, Inc. · Class II
- Care Orchestrator — Respironics, Inc. · Class II
- EncoreAnywhere — Respironics, Inc. · Class II
- Care Orchestrator — Respironics, Inc. · Class II
Cleared under the same submission
K141809 also covers:
- ACC Backboard — DEFIBTECH, L.L.C.
- ACC Backboard Configuration — DEFIBTECH, L.L.C.
- ACC Patient Interface Pad — DEFIBTECH, L.L.C.
- ACC Rechargeble Battery Pack — DEFIBTECH, L.L.C.
- ACC Rechargeble Battery Pack Configuration — DEFIBTECH, L.L.C.
- Defibtech ACC Compression Module — DEFIBTECH, L.L.C.
- Defibtech ACC Compression Module — DEFIBTECH, L.L.C.
- Defibtech ACC Configuration — DEFIBTECH, L.L.C.
- Defibtech ACC Configuration — DEFIBTECH, L.L.C.
- Defibtech ACC Frame — DEFIBTECH, L.L.C.
- Defibtech ACC Frame Configuration — DEFIBTECH, L.L.C.
- Defibtech ACC Stablization Strap — DEFIBTECH, L.L.C.
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
- Defibtech, L.l.c.
Sources (1)
- FDA UDI f2745699-ace2-49c9-88c7-e04c9d914436 33 fields · synced May 31, 2026