Identity
- Trade Name
- MRI Patient Monitoring System Tesla M3 FDA UDI
- Generic Name
- MRI-patient physiologic monitoring system FDA UDI
- Device Name
- The MRI Patient Monitoring System Tesla M3 is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients. FDA UDI
- Model / Reference
- TeslaM3 FDA UDI
- Description
- The MRI Patient Monitoring System Tesla M3 is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients. FDA UDI
Identifiers
- Catalog Number
- 1800001 FDA UDI
- Primary DI / UDI-DI
- EMIP18000010 FDA UDI
- 510(k) Number
- K142032 FDA UDI
- FDA Product Code
- MWI FDA UDI
- GMDN Term
- MRI-patient physiologic monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 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 Conditional FDA UDI
Category: MRI-patient physiologic monitoring system
MRI Patient Monitoring System Tesla M3 by MIPM Mammendorfer Institut für Physik und Medizin GmbH — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as MRI-patient physiologic monitoring system.
- Iradimed — Iradimed Corporation · Class II
- Iradimed — Iradimed Corporation · Class II
- Iradimed — Iradimed Corporation · Class II
- Iradimed — Iradimed Corporation · Class II
- Tesla M3 Remote Monitor — Mipm Mammendorfer Institut Fur Physik Und Medizin · Class II
- Iradimed — Iradimed Corporation · Class II
- MRI Patient Moitor Tesla DUO — MIPM Mammendorfer Institut für Physik und Medizin GmbH · Class II
- MRI Patient Monitoring System Tesla M3 — MIPM Mammendorfer Institut für Physik und Medizin GmbH · Class II
Cleared under the same submission
K142032 also covers:
- CO2 Adult Nasal Line — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- CO2 Airway Adapter — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- CO2 Monitoring Line M/M — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- CO2 Water Trap — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Fiber Optic Temperature Sensor Core — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Fiber Optic Temperature Sensor Core — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Fiber Optic Temperature Sensor Surface — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Gas Sample Line Set — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Gating Cable - Siemens — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- IBP Interface cable (BD/Ohmeda - Argon Medical) — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- IBP Interface cable (BD/Ohmeda - Argon Medical) — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- IBP Interface cable (Edwards / Baxter - Edwards Lifesciences) — MIPM Mammendorfer Institut für Physik und Medizin GmbH
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
Sources (1)
- FDA UDI b6835f20-40d4-4fd7-9f56-677d98009ebf 36 fields · synced May 30, 2026