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FDA 510(k)

ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D

K-Number: K043612 · 2005-02-09

ApplicantInstrumentarium Corp. Imaging Division
Decision Date2005-02-09
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Corp. Imaging Division. It received FDA 510(k) clearance on 2005-02-09 under 510(k) number K043612. 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 OP200, OP200D, AND ORTHOCEPH OC200, OC200D?

ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D is a medical device that received FDA 510(k) clearance on 2005-02-09. The listed applicant is Instrumentarium Corp. Imaging Division. The 510(k) number is K043612.

When did ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D receive FDA 510(k) clearance?

ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D received FDA 510(k) clearance on 2005-02-09, under 510(k) number K043612.

Who is the listed applicant for ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D?

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

What is the FDA product code for ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D?

The FDA product code for ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D is EHD.

Related Clinical Trials

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Other records listing Instrumentarium Corp. Imaging Division 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.

K023864PERFORMA STEREOK022275DELTA 32; DELTA 32 TACT

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

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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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