FDA 510(k)

CSP

K-Number: K912448 · 1991-08-28

Decision Date1991-08-28

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CSP is the device name listed in this FDA 510(k) record. The listed applicant is Fischer Imaging Corp.. It received FDA 510(k) clearance on 1991-08-28 under 510(k) number K912448. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CSP?

CSP is a medical device that received FDA 510(k) clearance on 1991-08-28. The listed applicant is Fischer Imaging Corp.. The 510(k) number is K912448.

When did CSP receive FDA 510(k) clearance?

CSP received FDA 510(k) clearance on 1991-08-28, under 510(k) number K912448.

Who is the listed applicant for CSP?

The FDA 510(k) record lists Fischer Imaging Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CSP?

The FDA product code for CSP is OWB.

Other records listing Fischer Imaging Corp. as applicant

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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.