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FDA 510(k)

TRANSDUCER FOR KONTROL 5MHZ SIGMA 20

K-Number: K843355 · 1984-12-03

ApplicantKontron Instruments, Inc.
Decision Date1984-12-03
Product CodeMHZ
DecisionSubstantially Equivalent

Device Summary

TRANSDUCER FOR KONTROL 5MHZ SIGMA 20 is the device name listed in this FDA 510(k) record. The listed applicant is Kontron Instruments, Inc.. It received FDA 510(k) clearance on 1984-12-03 under 510(k) number K843355. The device is classified under product code MHZ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSDUCER FOR KONTROL 5MHZ SIGMA 20?

TRANSDUCER FOR KONTROL 5MHZ SIGMA 20 is a medical device that received FDA 510(k) clearance on 1984-12-03. The listed applicant is Kontron Instruments, Inc.. The 510(k) number is K843355.

When did TRANSDUCER FOR KONTROL 5MHZ SIGMA 20 receive FDA 510(k) clearance?

TRANSDUCER FOR KONTROL 5MHZ SIGMA 20 received FDA 510(k) clearance on 1984-12-03, under 510(k) number K843355.

Who is the listed applicant for TRANSDUCER FOR KONTROL 5MHZ SIGMA 20?

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

What is the FDA product code for TRANSDUCER FOR KONTROL 5MHZ SIGMA 20?

The FDA product code for TRANSDUCER FOR KONTROL 5MHZ SIGMA 20 is MHZ.

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Other records listing Kontron Instruments, 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.

K932268MODIFICATIONS TO INTRA-AORTIC BALLOONSK925248MODIFICATION OF INTRA-AORTIC BALLOON CATHETERSK923603INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATIONK905313KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT IIK9033449.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)K896437KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM

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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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