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FDA 510(k)

PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR

K-Number: K883965 · 1988-10-05

ApplicantTeknar, Inc.
Decision Date1988-10-05
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Teknar, Inc.. It received FDA 510(k) clearance on 1988-10-05 under 510(k) number K883965. 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 PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR?

PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR is a medical device that received FDA 510(k) clearance on 1988-10-05. The listed applicant is Teknar, Inc.. The 510(k) number is K883965.

When did PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR receive FDA 510(k) clearance?

PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR received FDA 510(k) clearance on 1988-10-05, under 510(k) number K883965.

Who is the listed applicant for PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR?

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 PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR?

The FDA product code for PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR 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 NEEDLEK881850TEKNAR PERCU-SCANK881605BIOPSY GUIDE

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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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