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FDA 510(k)

DIATRON PICTUS 400

K-Number: K101741 · 2011-01-25

ApplicantDiatron Group
Decision Date2011-01-25
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIATRON PICTUS 400 is the device name listed in this FDA 510(k) record. The listed applicant is Diatron Group. It received FDA 510(k) clearance on 2011-01-25 under 510(k) number K101741. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIATRON PICTUS 400?

DIATRON PICTUS 400 is a medical device that received FDA 510(k) clearance on 2011-01-25. The listed applicant is Diatron Group. The 510(k) number is K101741.

When did DIATRON PICTUS 400 receive FDA 510(k) clearance?

DIATRON PICTUS 400 received FDA 510(k) clearance on 2011-01-25, under 510(k) number K101741.

Who is the listed applicant for DIATRON PICTUS 400?

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

What is the FDA product code for DIATRON PICTUS 400?

The FDA product code for DIATRON PICTUS 400 is CGA.

Related Clinical Trials

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.

Other records listing Diatron Group 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.

Related Devices (Code: CGA)

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.

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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