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FDA 510(k)

BETASONIC III

K-Number: K850116 · 1985-03-29

ApplicantTeknar, Inc.
Decision Date1985-03-29
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BETASONIC III is the device name listed in this FDA 510(k) record. The listed applicant is Teknar, Inc.. It received FDA 510(k) clearance on 1985-03-29 under 510(k) number K850116. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BETASONIC III?

BETASONIC III is a medical device that received FDA 510(k) clearance on 1985-03-29. The listed applicant is Teknar, Inc.. The 510(k) number is K850116.

When did BETASONIC III receive FDA 510(k) clearance?

BETASONIC III received FDA 510(k) clearance on 1985-03-29, under 510(k) number K850116.

Who is the listed applicant for BETASONIC III?

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 BETASONIC III?

The FDA product code for BETASONIC III is IYO.

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Other records listing Teknar, Inc. 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.

K903666OPHTHASONIC A/P IIIK896038B-SCAN 10 MHZ PROBEK896150IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONICK891777PRO-CUT BIOPSY NEEDLEK883965PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTORK881850TEKNAR PERCU-SCAN

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Related Devices (Code: IYO)

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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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