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FDA 510(k)

ORTHOPANTOMOGRAPH OP100D

K-Number: K992385 · 1999-09-28

ApplicantInstrumentarium Corp.
Decision Date1999-09-28
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHOPANTOMOGRAPH OP100D is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Corp.. It received FDA 510(k) clearance on 1999-09-28 under 510(k) number K992385. 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 ORTHOPANTOMOGRAPH OP100D?

ORTHOPANTOMOGRAPH OP100D is a medical device that received FDA 510(k) clearance on 1999-09-28. The listed applicant is Instrumentarium Corp.. The 510(k) number is K992385.

When did ORTHOPANTOMOGRAPH OP100D receive FDA 510(k) clearance?

ORTHOPANTOMOGRAPH OP100D received FDA 510(k) clearance on 1999-09-28, under 510(k) number K992385.

Who is the listed applicant for ORTHOPANTOMOGRAPH OP100D?

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 ORTHOPANTOMOGRAPH OP100D?

The FDA product code for ORTHOPANTOMOGRAPH OP100D is MUH.

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Other records listing Instrumentarium Corp. as applicant

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Related Devices (Code: MUH)

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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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