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MRI Patient Monitor Tesla DUO

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 1700001

by MIPM Mammendorfer Institut für Physik und Medizin GmbH

Identity

Trade Name
MRI Patient Monitor Tesla DUO EUDAMED
MRI Patient Monitor TeslaDUO FDA UDI
Generic Name
MRI-patient physiologic monitoring system FDA UDI
Device Name
TeslaDUO MRI Patient Monitor EUDAMED
The MRI Patient Monitor TeslaDUO is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients. FDA UDI
Model / Reference
1700001 EUDAMED
TeslaDUO FDA UDI
Description
The MRI Patient Monitor TeslaDUO is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients. FDA UDI

Identifiers

Catalog Number
1700001 FDA UDI
Primary DI / UDI-DI
04255629200508 EUDAMEDFDA UDI
Basic UDI-DI
42556292001025M5 EUDAMED
510(k) Number
K153739 FDA UDI
FDA Product Code
MWI FDA UDI
EMDN Code
Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
GMDN Term
MRI-patient physiologic monitoring system FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
870.2300 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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
MRI Safety
MR Conditional FDA UDI

MRI Patient Monitor Tesla DUO by MIPM Mammendorfer Institut für Physik und Medizin GmbH — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
MIPM Mammendorfer Institut für Physik und Medizin GmbH
EUDAMED SRN
DE-MF-000007654

Sources (3)

  • EUDAMED c46e2697-1d35-48d0-b548-5fe6c241cc99 61 fields · synced Oct 6, 2026
  • FDA UDI 1ffd5826-a6ab-4a30-b480-33904943c1d9 36 fields · synced May 30, 2026
  • FDA 510(k) K153739 1 fields · synced May 18, 2026