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FDA 510(k)

AMERICA SYSTEM

K-Number: K920608 · 1992-06-19

ApplicantI. Klimov Co.
Decision Date1992-06-19
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AMERICA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is I. Klimov Co.. It received FDA 510(k) clearance on 1992-06-19 under 510(k) number K920608. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERICA SYSTEM?

AMERICA SYSTEM is a medical device that received FDA 510(k) clearance on 1992-06-19. The listed applicant is I. Klimov Co.. The 510(k) number is K920608.

When did AMERICA SYSTEM receive FDA 510(k) clearance?

AMERICA SYSTEM received FDA 510(k) clearance on 1992-06-19, under 510(k) number K920608.

Who is the listed applicant for AMERICA SYSTEM?

The FDA 510(k) record lists I. Klimov Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMERICA SYSTEM?

The FDA product code for AMERICA SYSTEM is KTT.

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Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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