FDA 510(k)

IF8000

K-Number: K991241 · 1999-11-02

Decision Date1999-11-02

Product CodeIPF

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

IF8000 is the device name listed in this FDA 510(k) record. The listed applicant is Dan Med, Inc.. It received FDA 510(k) clearance on 1999-11-02 under 510(k) number K991241. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IF8000?

IF8000 is a medical device that received FDA 510(k) clearance on 1999-11-02. The listed applicant is Dan Med, Inc.. The 510(k) number is K991241.

When did IF8000 receive FDA 510(k) clearance?

IF8000 received FDA 510(k) clearance on 1999-11-02, under 510(k) number K991241.

Who is the listed applicant for IF8000?

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

What is the FDA product code for IF8000?

The FDA product code for IF8000 is IPF.

Other records listing Dan Med, 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.

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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.