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FDA 510(k)

INFANT CARE SYSTEM

K-Number: K823899 · 1983-04-14

ApplicantNarco Scientific
Decision Date1983-04-14
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFANT CARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Narco Scientific. It received FDA 510(k) clearance on 1983-04-14 under 510(k) number K823899. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFANT CARE SYSTEM?

INFANT CARE SYSTEM is a medical device that received FDA 510(k) clearance on 1983-04-14. The listed applicant is Narco Scientific. The 510(k) number is K823899.

When did INFANT CARE SYSTEM receive FDA 510(k) clearance?

INFANT CARE SYSTEM received FDA 510(k) clearance on 1983-04-14, under 510(k) number K823899.

Who is the listed applicant for INFANT CARE SYSTEM?

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

What is the FDA product code for INFANT CARE SYSTEM?

The FDA product code for INFANT CARE SYSTEM is FMI.

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Other records listing Narco Scientific as applicant

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Related Devices (Code: FMI)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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