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FDA 510(k)

MRI COMPATIBLE MONITOR AND ACCESSORIES

K-Number: K980362 · 1998-06-30

ApplicantDatex-Engstrom, Inc.
Decision Date1998-06-30
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MRI COMPATIBLE MONITOR AND ACCESSORIES 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 1998-06-30 under 510(k) number K980362. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRI COMPATIBLE MONITOR AND ACCESSORIES?

MRI COMPATIBLE MONITOR AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1998-06-30. The listed applicant is Datex-Engstrom, Inc.. The 510(k) number is K980362.

When did MRI COMPATIBLE MONITOR AND ACCESSORIES receive FDA 510(k) clearance?

MRI COMPATIBLE MONITOR AND ACCESSORIES received FDA 510(k) clearance on 1998-06-30, under 510(k) number K980362.

Who is the listed applicant for MRI COMPATIBLE MONITOR AND ACCESSORIES?

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 MRI COMPATIBLE MONITOR AND ACCESSORIES?

The FDA product code for MRI COMPATIBLE MONITOR AND ACCESSORIES is DPS.

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Other records listing Datex-Engstrom, Inc. 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.

K983366TRIP TONOMETRY CATHETER, 16FK982091CS/3 COMPACT AIRWAY MODULE, M-COVXK981378DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1K973985AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)K974792CS/3(TM) MONITORS*K980384TRIP TONOMETRY CATHETER, 18F

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Related Devices (Code: DPS)

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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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