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FDA 510(k)

INFANT PHOTOTHERAPY MASK

K-Number: K851918 · 1985-06-07

ApplicantAlba Health Care
Decision Date1985-06-07
Product CodeFOK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFANT PHOTOTHERAPY MASK is the device name listed in this FDA 510(k) record. The listed applicant is Alba Health Care. It received FDA 510(k) clearance on 1985-06-07 under 510(k) number K851918. 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 INFANT PHOTOTHERAPY MASK?

INFANT PHOTOTHERAPY MASK is a medical device that received FDA 510(k) clearance on 1985-06-07. The listed applicant is Alba Health Care. The 510(k) number is K851918.

When did INFANT PHOTOTHERAPY MASK receive FDA 510(k) clearance?

INFANT PHOTOTHERAPY MASK received FDA 510(k) clearance on 1985-06-07, under 510(k) number K851918.

Who is the listed applicant for INFANT PHOTOTHERAPY MASK?

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

What is the FDA product code for INFANT PHOTOTHERAPY MASK?

The FDA product code for INFANT PHOTOTHERAPY MASK is FOK.

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 Alba Health Care 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.

K864689ALBA HEALTH CARE IODOFORM PACKING STRIPK861154ALBA HEALTH CARE PLAIN PACKING STRIPK850904ALBA DRY BURN DRESSINGK850881ALBA DRY BURN PADK850241ALBA HEALTH CARE NON-ADHERING DRESSINGK812904STERILE ORTHOPEDIC STOCKINETTE

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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.K926118LIFE TRACE(R) BILIRUBIN MASKGraphic Controls Corp.K840894PHOTO-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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