Identity
- Trade Name
- CARDIOVIT® AT-2 plus FDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- The CARDIOVIT® AT-2 plus is a 12-lead ECG device used for the recording, analysis and evaluation of ECG recordings. FDA UDI
- Model / Reference
- 3.911013 FDA UDI
- Description
- The CARDIOVIT® AT-2 plus is a 12-lead ECG device used for the recording, analysis and evaluation of ECG recordings. FDA UDI
Identifiers
- Catalog Number
- 3.911013 FDA UDI
- Primary DI / UDI-DI
- 07613365000016 FDA UDI
- 510(k) Number
- K953396 FDA UDI
- FDA Product Code
- DPS FDA UDI
- GMDN Term
- Electrocardiograph, professional, multichannel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2340 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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electrocardiograph, professional, multichannel
CARDIOVIT® AT-2 plus by Schiller Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiograph, professional, multichannel.
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- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Premier Heart MCG Model VH12 — PREMIER HEART, LLC · Class II
- ELI 380 — MORTARA INSTRUMENT, INC. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
Cleared under the same submission
K953396 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
- Schiller Corp.
Sources (1)
- FDA UDI bca49496-39b4-49a0-a72f-cfd56468d2bb 37 fields · synced Jun 1, 2026