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FDA 510(k)

ORTHOCEPH OC100 D

K-Number: K001439 · 2000-06-22

ApplicantInstrumentarium Corp.
Decision Date2000-06-22
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHOCEPH OC100 D is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Corp.. It received FDA 510(k) clearance on 2000-06-22 under 510(k) number K001439. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOCEPH OC100 D?

ORTHOCEPH OC100 D is a medical device that received FDA 510(k) clearance on 2000-06-22. The listed applicant is Instrumentarium Corp.. The 510(k) number is K001439.

When did ORTHOCEPH OC100 D receive FDA 510(k) clearance?

ORTHOCEPH OC100 D received FDA 510(k) clearance on 2000-06-22, under 510(k) number K001439.

Who is the listed applicant for ORTHOCEPH OC100 D?

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

What is the FDA product code for ORTHOCEPH OC100 D?

The FDA product code for ORTHOCEPH OC100 D is MUH.

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Other records listing Instrumentarium Corp. as applicant

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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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