FDA 510(k)

ENZAC INCUBATOR

K-Number: K781501 · 1978-10-03

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1978-10-03

Product CodeJRG

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ENZAC INCUBATOR is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1978-10-03 under 510(k) number K781501. The device is classified under product code JRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZAC INCUBATOR?

ENZAC INCUBATOR is a medical device that received FDA 510(k) clearance on 1978-10-03. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K781501.

When did ENZAC INCUBATOR receive FDA 510(k) clearance?

ENZAC INCUBATOR received FDA 510(k) clearance on 1978-10-03, under 510(k) number K781501.

Who is the listed applicant for ENZAC INCUBATOR?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENZAC INCUBATOR?

The FDA product code for ENZAC INCUBATOR is JRG.

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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.