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FDA 510(k)

MODEL 5650 OPTIMATE PERSONAL PROGRAMMER

K-Number: K884522 · 1989-08-25

ApplicantTeletronics, Inc.
Decision Date1989-08-25
Product CodeKRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 5650 OPTIMATE PERSONAL PROGRAMMER is the device name listed in this FDA 510(k) record. The listed applicant is Teletronics, Inc.. It received FDA 510(k) clearance on 1989-08-25 under 510(k) number K884522. The device is classified under product code KRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 5650 OPTIMATE PERSONAL PROGRAMMER?

MODEL 5650 OPTIMATE PERSONAL PROGRAMMER is a medical device that received FDA 510(k) clearance on 1989-08-25. The listed applicant is Teletronics, Inc.. The 510(k) number is K884522.

When did MODEL 5650 OPTIMATE PERSONAL PROGRAMMER receive FDA 510(k) clearance?

MODEL 5650 OPTIMATE PERSONAL PROGRAMMER received FDA 510(k) clearance on 1989-08-25, under 510(k) number K884522.

Who is the listed applicant for MODEL 5650 OPTIMATE PERSONAL PROGRAMMER?

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

What is the FDA product code for MODEL 5650 OPTIMATE PERSONAL PROGRAMMER?

The FDA product code for MODEL 5650 OPTIMATE PERSONAL PROGRAMMER is KRG.

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Related Devices (Code: KRG)

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.

K933278INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04Intermedics, Inc.K880738MODEL 2331T PATIENT PROGRAMMERMedtronic VascularK882429MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004Tpl-Cordis, Inc.K864712MODEL 1740 PERSONAL POCKET PROGRAMMERTelectronics, Inc.K871986MODEL 5600B PROGRAMMER, PACEMAKERTelectronics, Inc.K863046ULTRA SOFTWARE MODULE: MODEL 2016Cardiac Pacemakers, 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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