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FDA 510(k)

TESLA GUARD, MODEL EFT G04

K-Number: K071802 · 2007-11-09

ApplicantMammendorfer Institut Fur Physik Und Medizin GmbH
Decision Date2007-11-09
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TESLA GUARD, MODEL EFT G04 is the device name listed in this FDA 510(k) record. The listed applicant is Mammendorfer Institut Fur Physik Und Medizin GmbH. It received FDA 510(k) clearance on 2007-11-09 under 510(k) number K071802. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TESLA GUARD, MODEL EFT G04?

TESLA GUARD, MODEL EFT G04 is a medical device that received FDA 510(k) clearance on 2007-11-09. The listed applicant is Mammendorfer Institut Fur Physik Und Medizin GmbH. The 510(k) number is K071802.

When did TESLA GUARD, MODEL EFT G04 receive FDA 510(k) clearance?

TESLA GUARD, MODEL EFT G04 received FDA 510(k) clearance on 2007-11-09, under 510(k) number K071802.

Who is the listed applicant for TESLA GUARD, MODEL EFT G04?

The FDA 510(k) record lists Mammendorfer Institut Fur Physik Und Medizin GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TESLA GUARD, MODEL EFT G04?

The FDA product code for TESLA GUARD, MODEL EFT G04 is MWI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Mammendorfer Institut Fur Physik Und Medizin GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K062974TESLA NIBP

Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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