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FDA 510(k)

ROENTGENOGRAPHY SET

K-Number: K830229 · 1983-03-09

ApplicantMallinckrodt Critical Care
Decision Date1983-03-09
Product CodeDGD
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ROENTGENOGRAPHY SET is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1983-03-09 under 510(k) number K830229. The device is classified under product code DGD. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROENTGENOGRAPHY SET?

ROENTGENOGRAPHY SET is a medical device that received FDA 510(k) clearance on 1983-03-09. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K830229.

When did ROENTGENOGRAPHY SET receive FDA 510(k) clearance?

ROENTGENOGRAPHY SET received FDA 510(k) clearance on 1983-03-09, under 510(k) number K830229.

Who is the listed applicant for ROENTGENOGRAPHY SET?

The FDA 510(k) record lists Mallinckrodt Critical Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROENTGENOGRAPHY SET?

The FDA product code for ROENTGENOGRAPHY SET is DGD.

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Other records listing Mallinckrodt Critical Care as applicant

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Related Devices (Code: DGD)

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.

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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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