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FDA 510(k)

CD-R STATION AND VRS-2000

K-Number: K974255 · 1998-01-27

ApplicantElectromed Intl., Ltd.
Decision Date1998-01-27
Product CodeLMD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CD-R STATION AND VRS-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Electromed Intl., Ltd.. It received FDA 510(k) clearance on 1998-01-27 under 510(k) number K974255. The device is classified under product code LMD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CD-R STATION AND VRS-2000?

CD-R STATION AND VRS-2000 is a medical device that received FDA 510(k) clearance on 1998-01-27. The listed applicant is Electromed Intl., Ltd.. The 510(k) number is K974255.

When did CD-R STATION AND VRS-2000 receive FDA 510(k) clearance?

CD-R STATION AND VRS-2000 received FDA 510(k) clearance on 1998-01-27, under 510(k) number K974255.

Who is the listed applicant for CD-R STATION AND VRS-2000?

The FDA 510(k) record lists Electromed Intl., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CD-R STATION AND VRS-2000?

The FDA product code for CD-R STATION AND VRS-2000 is LMD.

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Other records listing Electromed Intl., Ltd. 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.

K003688VIEW READING STATIONK000474VIEW NTK990759VIEW COMK971176VIEW ARCHIVING STATIONK950694COMPACT-XK880050EDEC 60R

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Related Devices (Code: LMD)

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.

K994329IIVS INTEGRATED IMAGE VIEWING STATIONTerarecon,Inc.K992698STENTOR, PAGEVIEWStentor, Inc.K992426RAYPAX WEB CLINICAL SYSTEMSamsung Sds Co., Ltd.K992352ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0Inteleradiology, Inc.K991537SAMSUNG RAYPAX SYSTEMSamsung Sds Co., Ltd.K984000STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEMSurgical Navigation Technologies, Inc.

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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