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FDA 510(k)

MODEL I-2000 MONITOR

K-Number: K072382 · 2008-02-15

ApplicantInfinite Biomedical Technologies
Decision Date2008-02-15
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL I-2000 MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Infinite Biomedical Technologies. It received FDA 510(k) clearance on 2008-02-15 under 510(k) number K072382. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL I-2000 MONITOR?

MODEL I-2000 MONITOR is a medical device that received FDA 510(k) clearance on 2008-02-15. The listed applicant is Infinite Biomedical Technologies. The 510(k) number is K072382.

When did MODEL I-2000 MONITOR receive FDA 510(k) clearance?

MODEL I-2000 MONITOR received FDA 510(k) clearance on 2008-02-15, under 510(k) number K072382.

Who is the listed applicant for MODEL I-2000 MONITOR?

The FDA 510(k) record lists Infinite Biomedical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL I-2000 MONITOR?

The FDA product code for MODEL I-2000 MONITOR is OLT.

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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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