FDA 510(k)

ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE

K-Number: K850861 · 1986-02-18

Decision Date1986-02-18

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc.. It received FDA 510(k) clearance on 1986-02-18 under 510(k) number K850861. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE?

ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE is a medical device that received FDA 510(k) clearance on 1986-02-18. The listed applicant is Medical Components, Inc.. The 510(k) number is K850861.

When did ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE receive FDA 510(k) clearance?

ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE received FDA 510(k) clearance on 1986-02-18, under 510(k) number K850861.

Who is the listed applicant for ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE?

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

What is the FDA product code for ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE?

The FDA product code for ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE is DXT.

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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.