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FDA 510(k)

IT/IF CONTROL

K-Number: K101863 · 2011-11-07

ApplicantSebia
Decision Date2011-11-07
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IT/IF CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2011-11-07 under 510(k) number K101863. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IT/IF CONTROL?

IT/IF CONTROL is a medical device that received FDA 510(k) clearance on 2011-11-07. The listed applicant is Sebia. The 510(k) number is K101863.

When did IT/IF CONTROL receive FDA 510(k) clearance?

IT/IF CONTROL received FDA 510(k) clearance on 2011-11-07, under 510(k) number K101863.

Who is the listed applicant for IT/IF CONTROL?

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

What is the FDA product code for IT/IF CONTROL?

The FDA product code for IT/IF CONTROL is JJY.

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 Sebia 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: JJY)

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

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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