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FDA 510(k)

TRANSESOPHAGEAL TRANSDUCER PEF-511SA

K-Number: K890969 · 1989-05-16

ApplicantToshiba Medical Systems
Decision Date1989-05-16
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRANSESOPHAGEAL TRANSDUCER PEF-511SA is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba Medical Systems. It received FDA 510(k) clearance on 1989-05-16 under 510(k) number K890969. 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 TRANSESOPHAGEAL TRANSDUCER PEF-511SA?

TRANSESOPHAGEAL TRANSDUCER PEF-511SA is a medical device that received FDA 510(k) clearance on 1989-05-16. The listed applicant is Toshiba Medical Systems. The 510(k) number is K890969.

When did TRANSESOPHAGEAL TRANSDUCER PEF-511SA receive FDA 510(k) clearance?

TRANSESOPHAGEAL TRANSDUCER PEF-511SA received FDA 510(k) clearance on 1989-05-16, under 510(k) number K890969.

Who is the listed applicant for TRANSESOPHAGEAL TRANSDUCER PEF-511SA?

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

What is the FDA product code for TRANSESOPHAGEAL TRANSDUCER PEF-511SA?

The FDA product code for TRANSESOPHAGEAL TRANSDUCER PEF-511SA is IYO.

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Other records listing Toshiba Medical Systems 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.

K960948SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020AK954310BLA-800AK954309ANGIOREXK893750MRT-50A MOBILEK891453DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582VK884788TOSHIBA TCT-600XT COMPUTED TOMOGRAPHY X-RAY SYSTEM

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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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