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FDA 510(k)

INOBLENDER

K-Number: K122689 · 2012-11-07

ApplicantIno Therapeutics
Decision Date2012-11-07
Product CodeMRO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INOBLENDER is the device name listed in this FDA 510(k) record. The listed applicant is Ino Therapeutics. It received FDA 510(k) clearance on 2012-11-07 under 510(k) number K122689. The device is classified under product code MRO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INOBLENDER?

INOBLENDER is a medical device that received FDA 510(k) clearance on 2012-11-07. The listed applicant is Ino Therapeutics. The 510(k) number is K122689.

When did INOBLENDER receive FDA 510(k) clearance?

INOBLENDER received FDA 510(k) clearance on 2012-11-07, under 510(k) number K122689.

Who is the listed applicant for INOBLENDER?

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

What is the FDA product code for INOBLENDER?

The FDA product code for INOBLENDER is MRO.

Related Clinical Trials

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Other records listing Ino Therapeutics 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.

K130605INOMAX DSIR (DELIVERY SYSTEM)K121021INOMAX DS (DELIVERY SYSTEM)K110344INOMAX DSIR (DELIVERY SYSTEM)K093922INOMAX DSK080484INOMAX DS (DELIVERY SYSTEM), MODEL 10003K061901INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003

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Related Devices (Code: MRO)

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.

K052663INO THERAPEUTICS INOBLENDER, MODEL 10004Ino TherapeuticsK011874FADASIS MEDICAL FM-1 NO BLENDERFadasis Medical, Inc.K003665FADASSI MEDICAL FM-1 NO BLENDERFadasis Medical, Inc.

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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