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FDA 510(k)

NEONATAL UNILET

K-Number: K861243 · 1986-04-29

ApplicantUlster Scientific, Inc.
Decision Date1986-04-29
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEONATAL UNILET is the device name listed in this FDA 510(k) record. The listed applicant is Ulster Scientific, Inc.. It received FDA 510(k) clearance on 1986-04-29 under 510(k) number K861243. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEONATAL UNILET?

NEONATAL UNILET is a medical device that received FDA 510(k) clearance on 1986-04-29. The listed applicant is Ulster Scientific, Inc.. The 510(k) number is K861243.

When did NEONATAL UNILET receive FDA 510(k) clearance?

NEONATAL UNILET received FDA 510(k) clearance on 1986-04-29, under 510(k) number K861243.

Who is the listed applicant for NEONATAL UNILET?

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

What is the FDA product code for NEONATAL UNILET?

The FDA product code for NEONATAL UNILET is FMK.

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Other records listing Ulster Scientific, Inc. as applicant

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Related Devices (Code: FMK)

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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