FDA 510(k)

SPIRAFLOW 2001, MULTI-DIRECTIONAL TOMOGRAPHIC UNIT

K-Number: K827346 · 1983-02-14

Decision Date1983-02-14

Product Code

DecisionSubstantially Equivalent

Device Summary

SPIRAFLOW 2001, MULTI-DIRECTIONAL TOMOGRAPHIC UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Rayflow Italia S.R.L.. It received FDA 510(k) clearance on 1983-02-14 under 510(k) number K827346. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRAFLOW 2001, MULTI-DIRECTIONAL TOMOGRAPHIC UNIT?

SPIRAFLOW 2001, MULTI-DIRECTIONAL TOMOGRAPHIC UNIT is a medical device that received FDA 510(k) clearance on 1983-02-14. The listed applicant is Rayflow Italia S.R.L.. The 510(k) number is K827346.

When did SPIRAFLOW 2001, MULTI-DIRECTIONAL TOMOGRAPHIC UNIT receive FDA 510(k) clearance?

SPIRAFLOW 2001, MULTI-DIRECTIONAL TOMOGRAPHIC UNIT received FDA 510(k) clearance on 1983-02-14, under 510(k) number K827346.

Who is the listed applicant for SPIRAFLOW 2001, MULTI-DIRECTIONAL TOMOGRAPHIC UNIT?

The FDA 510(k) record lists Rayflow Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

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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.