Identity
- Trade Name
- Novi Software FDA UDI
- Generic Name
- Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
- Device Name
- Software used for the interaction and programming of the Novi Device. FDA UDI
- Model / Reference
- Novi Software FDA UDI
- Description
- Software used for the interaction and programming of the Novi Device. FDA UDI
Identifiers
- Catalog Number
- 101633 FDA UDI
- Primary DI / UDI-DI
- 00856298006237 FDA UDI
- 510(k) Number
- K042463 FDA UDI
- FDA Product Code
- DSH FDA UDI
- GMDN Term
- Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2800 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: Electrocardiographic long-term ambulatory recording analyser application software
Novi Software by Scottcare Corporation, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic long-term ambulatory recording analyser application software.
- HScribe — MORTARA INSTRUMENT, INC. · Class II
- Modality Manager — MORTARA INSTRUMENT, INC. · Class II
- Vision — MORTARA INSTRUMENT, INC. · Class II
- HScribe — MORTARA INSTRUMENT, INC. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Holter analysis software + Data base. Includes download device according to reco — Norav Medical Inc. · Class II
- Vasomedical-Biox™ ARCS S/W Dongle - Mini 1200/1201 2 & 3 CH ECG — VASOMEDICAL, INC. · Class II
- HScribe — MORTARA INSTRUMENT, INC. · Class II
Cleared under the same submission
K042463 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Scottcare Corporation, The
Sources (1)
- FDA UDI 7817eb50-462c-46a0-aa91-e8a6a5f7a4d2 36 fields · synced May 30, 2026