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FDA 510(k)

DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1

K-Number: K981378 · 1998-11-03

ApplicantDatex-Engstrom, Inc.
Decision Date1998-11-03
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 is the device name listed in this FDA 510(k) record. The listed applicant is Datex-Engstrom, Inc.. It received FDA 510(k) clearance on 1998-11-03 under 510(k) number K981378. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1?

DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 is a medical device that received FDA 510(k) clearance on 1998-11-03. The listed applicant is Datex-Engstrom, Inc.. The 510(k) number is K981378.

When did DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 receive FDA 510(k) clearance?

DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 received FDA 510(k) clearance on 1998-11-03, under 510(k) number K981378.

Who is the listed applicant for DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1?

The FDA 510(k) record lists Datex-Engstrom, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1?

The FDA product code for DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 is DRT.

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Related Devices (Code: DRT)

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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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