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FDA 510(k)

LULMITEX NEONATAL TRANSILLUMINATOR

K-Number: K912747 · 1991-12-24

ApplicantLumitex, Inc.
Decision Date1991-12-24
Product CodeHJN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LULMITEX NEONATAL TRANSILLUMINATOR is the device name listed in this FDA 510(k) record. The listed applicant is Lumitex, Inc.. It received FDA 510(k) clearance on 1991-12-24 under 510(k) number K912747. The device is classified under product code HJN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LULMITEX NEONATAL TRANSILLUMINATOR?

LULMITEX NEONATAL TRANSILLUMINATOR is a medical device that received FDA 510(k) clearance on 1991-12-24. The listed applicant is Lumitex, Inc.. The 510(k) number is K912747.

When did LULMITEX NEONATAL TRANSILLUMINATOR receive FDA 510(k) clearance?

LULMITEX NEONATAL TRANSILLUMINATOR received FDA 510(k) clearance on 1991-12-24, under 510(k) number K912747.

Who is the listed applicant for LULMITEX NEONATAL TRANSILLUMINATOR?

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

What is the FDA product code for LULMITEX NEONATAL TRANSILLUMINATOR?

The FDA product code for LULMITEX NEONATAL TRANSILLUMINATOR is HJN.

Related Clinical Trials

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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Other records listing Lumitex, Inc. as applicant

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.

K120820GIRAFFE BLUE SPOT PT LITEK053568BILISOFT PHOTOTHERAPY SYSTEM

Related Devices (Code: HJN)

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.

K941035VENOSCOPETrinity Partners, LLCK901309SYLVAN PEDIASCAN 200 TRANSILLUMINATORSylvan Corp.

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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