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FDA 510(k)

OZ POWER SYRINGE

K-Number: K973334 · 1998-04-03

ApplicantCardiovascular Innovations
Decision Date1998-04-03
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OZ POWER SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Innovations. It received FDA 510(k) clearance on 1998-04-03 under 510(k) number K973334. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OZ POWER SYRINGE?

OZ POWER SYRINGE is a medical device that received FDA 510(k) clearance on 1998-04-03. The listed applicant is Cardiovascular Innovations. The 510(k) number is K973334.

When did OZ POWER SYRINGE receive FDA 510(k) clearance?

OZ POWER SYRINGE received FDA 510(k) clearance on 1998-04-03, under 510(k) number K973334.

Who is the listed applicant for OZ POWER SYRINGE?

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

What is the FDA product code for OZ POWER SYRINGE?

The FDA product code for OZ POWER SYRINGE is DXT.

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Related Devices (Code: DXT)

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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