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FDA 510(k)

EXPLORER 3D

K-Number: K991815 · 1999-08-13

ApplicantOur Scientific Intl., Inc.
Decision Date1999-08-13
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXPLORER 3D is the device name listed in this FDA 510(k) record. The listed applicant is Our Scientific Intl., Inc.. It received FDA 510(k) clearance on 1999-08-13 under 510(k) number K991815. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPLORER 3D?

EXPLORER 3D is a medical device that received FDA 510(k) clearance on 1999-08-13. The listed applicant is Our Scientific Intl., Inc.. The 510(k) number is K991815.

When did EXPLORER 3D receive FDA 510(k) clearance?

EXPLORER 3D received FDA 510(k) clearance on 1999-08-13, under 510(k) number K991815.

Who is the listed applicant for EXPLORER 3D?

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

What is the FDA product code for EXPLORER 3D?

The FDA product code for EXPLORER 3D is MUJ.

Related Clinical Trials

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.

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Other records listing Our Scientific Intl., 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.

K970647OUR ROTATING GAMMA SYSTEM

Related Devices (Code: MUJ)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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