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FDA 510(k)

AXISONIC II

K-Number: K810697 · 1981-07-13

ApplicantTeknar, Inc.
Decision Date1981-07-13
Product CodeHDR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AXISONIC II is the device name listed in this FDA 510(k) record. The listed applicant is Teknar, Inc.. It received FDA 510(k) clearance on 1981-07-13 under 510(k) number K810697. The device is classified under product code HDR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXISONIC II?

AXISONIC II is a medical device that received FDA 510(k) clearance on 1981-07-13. The listed applicant is Teknar, Inc.. The 510(k) number is K810697.

When did AXISONIC II receive FDA 510(k) clearance?

AXISONIC II received FDA 510(k) clearance on 1981-07-13, under 510(k) number K810697.

Who is the listed applicant for AXISONIC II?

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

What is the FDA product code for AXISONIC II?

The FDA product code for AXISONIC II is HDR.

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Other records listing Teknar, Inc. as applicant

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Related Devices (Code: HDR)

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

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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