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FDA 510(k)

FIRM-A-TRON MARK X

K-Number: K843583 · 1984-11-29

ApplicantBiotron , Ltd.
Decision Date1984-11-29
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FIRM-A-TRON MARK X is the device name listed in this FDA 510(k) record. The listed applicant is Biotron , Ltd.. It received FDA 510(k) clearance on 1984-11-29 under 510(k) number K843583. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIRM-A-TRON MARK X?

FIRM-A-TRON MARK X is a medical device that received FDA 510(k) clearance on 1984-11-29. The listed applicant is Biotron , Ltd.. The 510(k) number is K843583.

When did FIRM-A-TRON MARK X receive FDA 510(k) clearance?

FIRM-A-TRON MARK X received FDA 510(k) clearance on 1984-11-29, under 510(k) number K843583.

Who is the listed applicant for FIRM-A-TRON MARK X?

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

What is the FDA product code for FIRM-A-TRON MARK X?

The FDA product code for FIRM-A-TRON MARK X is IPF.

Other records listing Biotron , Ltd. 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.

K910135THE UNIVERSAL CEMENT PLUG(TM)K810634FIRM-A-TRONK780802ARMTROL AND FERMTROLK780803TILL-U-TEST, DIP SLIDE

Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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