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FDA 510(k)

LIFE TRACE(R) BILIRUBIN MASK

K-Number: K926118 · 1993-03-15

ApplicantGraphic Controls Corp.
Decision Date1993-03-15
Product CodeFOK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LIFE TRACE(R) BILIRUBIN MASK is the device name listed in this FDA 510(k) record. The listed applicant is Graphic Controls Corp.. It received FDA 510(k) clearance on 1993-03-15 under 510(k) number K926118. The device is classified under product code FOK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFE TRACE(R) BILIRUBIN MASK?

LIFE TRACE(R) BILIRUBIN MASK is a medical device that received FDA 510(k) clearance on 1993-03-15. The listed applicant is Graphic Controls Corp.. The 510(k) number is K926118.

When did LIFE TRACE(R) BILIRUBIN MASK receive FDA 510(k) clearance?

LIFE TRACE(R) BILIRUBIN MASK received FDA 510(k) clearance on 1993-03-15, under 510(k) number K926118.

Who is the listed applicant for LIFE TRACE(R) BILIRUBIN MASK?

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

What is the FDA product code for LIFE TRACE(R) BILIRUBIN MASK?

The FDA product code for LIFE TRACE(R) BILIRUBIN MASK is FOK.

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Other records listing Graphic Controls Corp. as applicant

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K981964MEDI-TRACE 4103 NEONATAL ELECTRODEK983287MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODEK974730SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)K980857MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODEK972970MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODEK964387POINT OF USE II SHARPS-A-GATOR

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Related Devices (Code: FOK)

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.

K962290DEROYAL INDUSTRIES, INC. NEONATAL EYE COVERDebusk Technology Corp.K851918INFANT PHOTOTHERAPY MASKAlba Health CareK840894PHOTO-THERAPY EYE PROTECTORA & A Medical Supplies Co.K813214INFANT PHOTOTHERAPY MASKMontrose Phototherapy Supply

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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