Identity
- Trade Name
- SEER 1000 PC App FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- The SEER 1000 PC App is a software product which is an accessory to the SEER 1000 recorder. The SEER 1000 PC App assists in the hook-up procedure (e.g. displaying of ECG data and setting of patient demographic data). FDA UDI
- Model / Reference
- V1.0SP03 FDA UDI
- Description
- The SEER 1000 PC App is a software product which is an accessory to the SEER 1000 recorder. The SEER 1000 PC App assists in the hook-up procedure (e.g. displaying of ECG data and setting of patient demographic data). FDA UDI
Identifiers
- Catalog Number
- 2067634-055 FDA UDI
- Primary DI / UDI-DI
- 04250903201196 FDA UDI
- 510(k) Number
- K130785 FDA UDI
- FDA Product Code
- MWJ FDA UDI
- GMDN Term
- Electrocardiographic ambulatory recorder 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
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
Yes
FDA UDI
Category: Electrocardiographic ambulatory recorder
SEER 1000 PC App by getemed Medizin- und Informationstechnik AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic ambulatory recorder.
- Norav NR Series — Norav Medical Inc. · Class II
- Pouch — GLOBAL INSTRUMENTATION, LLC · Class II
- Mediblu — Mediblu Medical, LLC · Class II
- Norav NR Series — Norav Medical Inc. · Class II
- CardioSTAT — ICENTIA LLC · Class II
- ePatch Sensor 2.5, Rebuilt — Braemar Manufacturing, LLC · Class II
- Norav NR Series — Norav Medical Inc. · Class II
- Norav NR Series — Norav Medical Inc. · Class II
Cleared under the same submission
K130785 also covers:
- SEER — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- SEER — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- SEER — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- ECG Cable for SEER 1000 — getemed Medizin- und Informationstechnik AG
- ECG Cable for SEER 1000 — getemed Medizin- und Informationstechnik AG
- ECG Cable for SEER 1000 — getemed Medizin- und Informationstechnik AG
- ECG Cable for SEER 1000 — getemed Medizin- und Informationstechnik AG
- ECG Cable for SEER 1000 — getemed Medizin- und Informationstechnik AG
- ECG Cable for SEER 1000 — getemed Medizin- und Informationstechnik AG
- ECG Cable for SEER 1000 — getemed Medizin- und Informationstechnik AG
- ECG Cable for SEER 1000 — getemed Medizin- und Informationstechnik AG
- SEER 1000 Apple App — getemed Medizin- und Informationstechnik AG
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
- getemed Medizin- und Informationstechnik AG
Sources (1)
- FDA UDI a5d9d5dc-933f-4d8b-bbdb-b99fb9fc19b1 37 fields · synced May 30, 2026