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FDA 510(k)

FC-1000 FLUOROSCOPIC IMAGING COMPUTER

K-Number: K854810 · 1986-04-15

ApplicantInficon Leybold-Heraeus, Inc.
Decision Date1986-04-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FC-1000 FLUOROSCOPIC IMAGING COMPUTER is the device name listed in this FDA 510(k) record. The listed applicant is Inficon Leybold-Heraeus, Inc.. It received FDA 510(k) clearance on 1986-04-15 under 510(k) number K854810. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FC-1000 FLUOROSCOPIC IMAGING COMPUTER?

FC-1000 FLUOROSCOPIC IMAGING COMPUTER is a medical device that received FDA 510(k) clearance on 1986-04-15. The listed applicant is Inficon Leybold-Heraeus, Inc.. The 510(k) number is K854810.

When did FC-1000 FLUOROSCOPIC IMAGING COMPUTER receive FDA 510(k) clearance?

FC-1000 FLUOROSCOPIC IMAGING COMPUTER received FDA 510(k) clearance on 1986-04-15, under 510(k) number K854810.

Who is the listed applicant for FC-1000 FLUOROSCOPIC IMAGING COMPUTER?

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

What is the FDA product code for FC-1000 FLUOROSCOPIC IMAGING COMPUTER?

The FDA product code for FC-1000 FLUOROSCOPIC IMAGING COMPUTER is LLZ.

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Related Devices (Code: LLZ)

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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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