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FDA 510(k)

OPHTHASONIC A-SCAN

K-Number: K860757 · 1986-12-18

ApplicantTeknar, Inc.
Decision Date1986-12-18
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPHTHASONIC A-SCAN is the device name listed in this FDA 510(k) record. The listed applicant is Teknar, Inc.. It received FDA 510(k) clearance on 1986-12-18 under 510(k) number K860757. 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 OPHTHASONIC A-SCAN?

OPHTHASONIC A-SCAN is a medical device that received FDA 510(k) clearance on 1986-12-18. The listed applicant is Teknar, Inc.. The 510(k) number is K860757.

When did OPHTHASONIC A-SCAN receive FDA 510(k) clearance?

OPHTHASONIC A-SCAN received FDA 510(k) clearance on 1986-12-18, under 510(k) number K860757.

Who is the listed applicant for OPHTHASONIC A-SCAN?

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 OPHTHASONIC A-SCAN?

The FDA product code for OPHTHASONIC A-SCAN 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)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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