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FDA 510(k)

DMS-9000

K-Number: K960836 · 1996-09-12

ApplicantO.R. Solutions, Inc.
Decision Date1996-09-12
Product CodeLRJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DMS-9000 is the device name listed in this FDA 510(k) record. The listed applicant is O.R. Solutions, Inc.. It received FDA 510(k) clearance on 1996-09-12 under 510(k) number K960836. The device is classified under product code LRJ. It was reviewed by the HO advisory panel. Product code LRJ falls under the category of Clinical Lab, which includes general clinical laboratory instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DMS-9000?

DMS-9000 is a medical device that received FDA 510(k) clearance on 1996-09-12. The listed applicant is O.R. Solutions, Inc.. The 510(k) number is K960836.

When did DMS-9000 receive FDA 510(k) clearance?

DMS-9000 received FDA 510(k) clearance on 1996-09-12, under 510(k) number K960836.

Who is the listed applicant for DMS-9000?

The FDA 510(k) record lists O.R. Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DMS-9000?

The FDA product code for DMS-9000 is LRJ. This falls under the Clinical Lab category.

Other records listing O.R. Solutions, 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.

K051979ORS MODEL 6000 ENDOSCOPE HOLDERK0232831075LD HUSH-SLUSHK023282ORS-3000LDK021288ORS-1000LDK021289WARMER 2000LDK953654ORS-111

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Related Devices (Code: LRJ)

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.

K992661CONTROL III ELITEMaril Products, Inc.K991509PRO-PORTION CLEANER/DISINFECTANTSultan Chemists, Inc.K984485MICROSTAT 2Chemlink Laboratories, LLCK983947AMERSE 2STERIS CorporationK983869DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACHCaltech Industries, Inc.K983585LOW PH PHENOLIC 256Central Solutions, 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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