FDA 510(k)

FC2000

K-Number: K911454 · 1991-07-15

Decision Date1991-07-15

Product CodeJAA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

FC2000 is the device name listed in this FDA 510(k) record. The listed applicant is S & S Inficon, Inc.. It received FDA 510(k) clearance on 1991-07-15 under 510(k) number K911454. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FC2000?

FC2000 is a medical device that received FDA 510(k) clearance on 1991-07-15. The listed applicant is S & S Inficon, Inc.. The 510(k) number is K911454.

When did FC2000 receive FDA 510(k) clearance?

FC2000 received FDA 510(k) clearance on 1991-07-15, under 510(k) number K911454.

Who is the listed applicant for FC2000?

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

What is the FDA product code for FC2000?

The FDA product code for FC2000 is JAA.

Other records listing S & S Inficon, 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.

K922977EXPOSET K920455THERAVIEW DIGITAL PORTAL IMAGING COMPUTER (MOD.)K902339THERAVIEW DIGITAL PORTAL IMAGING COMPUTER

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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.