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FDA 510(k)

OMNI STIK

K-Number: K781616 · 1978-12-08

ApplicantUnitron Corp.
Decision Date1978-12-08
Product CodeCBT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OMNI STIK is the device name listed in this FDA 510(k) record. The listed applicant is Unitron Corp.. It received FDA 510(k) clearance on 1978-12-08 under 510(k) number K781616. The device is classified under product code CBT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI STIK?

OMNI STIK is a medical device that received FDA 510(k) clearance on 1978-12-08. The listed applicant is Unitron Corp.. The 510(k) number is K781616.

When did OMNI STIK receive FDA 510(k) clearance?

OMNI STIK received FDA 510(k) clearance on 1978-12-08, under 510(k) number K781616.

Who is the listed applicant for OMNI STIK?

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

What is the FDA product code for OMNI STIK?

The FDA product code for OMNI STIK is CBT.

Related Devices (Code: CBT)

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.

K071269HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.K070340SECURE ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.K955663ABC IN-LINE BLOOD SAMPLING KITUtah Medical Products, Inc.K954015ABG POINT LOK NEEDLE PROTECTION DEVICEDevon Industries, Inc.K954035ACTI-FLEX ARTERIAL EXTENSION SETR-Group Intl.K950098NEEDLE SAFETY COVERHammer-Plane, 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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