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FDA 510(k)

ORS-3000LD

K-Number: K023282 · 2002-11-13

Decision Date2002-11-13
Product CodeLHC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ORS-3000LD 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 2002-11-13 under 510(k) number K023282. The device is classified under product code LHC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORS-3000LD?

ORS-3000LD is a medical device that received FDA 510(k) clearance on 2002-11-13. The listed applicant is O.R. Solutions, Inc.. The 510(k) number is K023282.

When did ORS-3000LD receive FDA 510(k) clearance?

ORS-3000LD received FDA 510(k) clearance on 2002-11-13, under 510(k) number K023282.

Who is the listed applicant for ORS-3000LD?

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 ORS-3000LD?

The FDA product code for ORS-3000LD is LHC.

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.

View all 7 devices →

Related Devices (Code: LHC)

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.

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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