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FDA 510(k)

IBC FLOGUARD, MODEL 6050

K-Number: K992785 · 2000-01-14

ApplicantInternational Biophysics Corp.
Decision Date2000-01-14
Product CodeMJJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IBC FLOGUARD, MODEL 6050 is the device name listed in this FDA 510(k) record. The listed applicant is International Biophysics Corp.. It received FDA 510(k) clearance on 2000-01-14 under 510(k) number K992785. The device is classified under product code MJJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IBC FLOGUARD, MODEL 6050?

IBC FLOGUARD, MODEL 6050 is a medical device that received FDA 510(k) clearance on 2000-01-14. The listed applicant is International Biophysics Corp.. The 510(k) number is K992785.

When did IBC FLOGUARD, MODEL 6050 receive FDA 510(k) clearance?

IBC FLOGUARD, MODEL 6050 received FDA 510(k) clearance on 2000-01-14, under 510(k) number K992785.

Who is the listed applicant for IBC FLOGUARD, MODEL 6050?

The FDA 510(k) record lists International Biophysics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IBC FLOGUARD, MODEL 6050?

The FDA product code for IBC FLOGUARD, MODEL 6050 is MJJ.

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Other records listing International Biophysics Corp. 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.

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Related Devices (Code: MJJ)

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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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