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FDA 510(k)

STARTRAC

K-Number: K890793 · 1989-03-16

ApplicantUnisen, Inc.
Decision Date1989-03-16
Product CodeIOL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STARTRAC is the device name listed in this FDA 510(k) record. The listed applicant is Unisen, Inc.. It received FDA 510(k) clearance on 1989-03-16 under 510(k) number K890793. The device is classified under product code IOL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STARTRAC?

STARTRAC is a medical device that received FDA 510(k) clearance on 1989-03-16. The listed applicant is Unisen, Inc.. The 510(k) number is K890793.

When did STARTRAC receive FDA 510(k) clearance?

STARTRAC received FDA 510(k) clearance on 1989-03-16, under 510(k) number K890793.

Who is the listed applicant for STARTRAC?

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

What is the FDA product code for STARTRAC?

The FDA product code for STARTRAC is IOL.

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Related Devices (Code: IOL)

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.

K950376PARKER MODEL PMParker Treadmill Co., Inc.K950377PARKER MODEL PEParker Treadmill Co., Inc.K925839TRACKMASTERJas Manufacturing Co., Inc.K930261RTM REHABILITATION TREADMILL, MODEL #945-200Biodan Medical Systems, Ltd.K904556MANSFIELD CARDIAC ASSIST MODEL 940(TM) IABBoston Scientific CorpK913518TA620 TREADMILL CONTROLLERSiemens Burdick, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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