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FDA 510(k)

ADAPTATION OF KANTRON 40 CC. PDLIAB

K-Number: K820166 · 1982-04-29

ApplicantKontron Instruments, Inc.
Decision Date1982-04-29
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADAPTATION OF KANTRON 40 CC. PDLIAB 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 1982-04-29 under 510(k) number K820166. The device is classified under product code DSP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADAPTATION OF KANTRON 40 CC. PDLIAB?

ADAPTATION OF KANTRON 40 CC. PDLIAB is a medical device that received FDA 510(k) clearance on 1982-04-29. The listed applicant is Kontron Instruments, Inc.. The 510(k) number is K820166.

When did ADAPTATION OF KANTRON 40 CC. PDLIAB receive FDA 510(k) clearance?

ADAPTATION OF KANTRON 40 CC. PDLIAB received FDA 510(k) clearance on 1982-04-29, under 510(k) number K820166.

Who is the listed applicant for ADAPTATION OF KANTRON 40 CC. PDLIAB?

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 ADAPTATION OF KANTRON 40 CC. PDLIAB?

The FDA product code for ADAPTATION OF KANTRON 40 CC. PDLIAB is DSP.

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Other records listing Kontron Instruments, Inc. as applicant

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Related Devices (Code: DSP)

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.

K250542AC3™ Range™ Intra-Aortic Balloon PumpArrow International, LLCK232343AC3™ Series IABPArrow International, LLCK201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc.K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc.K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, TeleflexK190101UltraFlex IABArrow International, Inc.

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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