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FDA 510(k)

ORTHOPANTOMOGRAPH 100

K-Number: K912893 · 1991-11-05

ApplicantInstrumentarium Corp.
Decision Date1991-11-05
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHOPANTOMOGRAPH 100 is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Corp.. It received FDA 510(k) clearance on 1991-11-05 under 510(k) number K912893. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOPANTOMOGRAPH 100?

ORTHOPANTOMOGRAPH 100 is a medical device that received FDA 510(k) clearance on 1991-11-05. The listed applicant is Instrumentarium Corp.. The 510(k) number is K912893.

When did ORTHOPANTOMOGRAPH 100 receive FDA 510(k) clearance?

ORTHOPANTOMOGRAPH 100 received FDA 510(k) clearance on 1991-11-05, under 510(k) number K912893.

Who is the listed applicant for ORTHOPANTOMOGRAPH 100?

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 100?

The FDA product code for ORTHOPANTOMOGRAPH 100 is EHD.

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Other records listing Instrumentarium 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: EHD)

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

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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