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FDA 510(k)

#505 PORT. VITAL FUNCTIONS NEONATAL MON

K-Number: K820416 · 1982-03-04

ApplicantGe Medical Systems Information Technologies
Decision Date1982-03-04
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

#505 PORT. VITAL FUNCTIONS NEONATAL MON is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies. It received FDA 510(k) clearance on 1982-03-04 under 510(k) number K820416. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the #505 PORT. VITAL FUNCTIONS NEONATAL MON?

#505 PORT. VITAL FUNCTIONS NEONATAL MON is a medical device that received FDA 510(k) clearance on 1982-03-04. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K820416.

When did #505 PORT. VITAL FUNCTIONS NEONATAL MON receive FDA 510(k) clearance?

#505 PORT. VITAL FUNCTIONS NEONATAL MON received FDA 510(k) clearance on 1982-03-04, under 510(k) number K820416.

Who is the listed applicant for #505 PORT. VITAL FUNCTIONS NEONATAL MON?

The FDA 510(k) record lists Ge Medical Systems Information Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for #505 PORT. VITAL FUNCTIONS NEONATAL MON?

The FDA product code for #505 PORT. VITAL FUNCTIONS NEONATAL MON is DRT.

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Related Devices (Code: DRT)

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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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