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FDA 510(k)

NEONATAL PHOTOTHERAPY UNIT

K-Number: K802702 · 1980-12-10

ApplicantOhio Medical Products
Decision Date1980-12-10
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEONATAL PHOTOTHERAPY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Ohio Medical Products. It received FDA 510(k) clearance on 1980-12-10 under 510(k) number K802702. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEONATAL PHOTOTHERAPY UNIT?

NEONATAL PHOTOTHERAPY UNIT is a medical device that received FDA 510(k) clearance on 1980-12-10. The listed applicant is Ohio Medical Products. The 510(k) number is K802702.

When did NEONATAL PHOTOTHERAPY UNIT receive FDA 510(k) clearance?

NEONATAL PHOTOTHERAPY UNIT received FDA 510(k) clearance on 1980-12-10, under 510(k) number K802702.

Who is the listed applicant for NEONATAL PHOTOTHERAPY UNIT?

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

What is the FDA product code for NEONATAL PHOTOTHERAPY UNIT?

The FDA product code for NEONATAL PHOTOTHERAPY UNIT is LBI.

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Other records listing Ohio Medical Products 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.

K841733OHIO WASTE GAS SCAVENGING RESERVOIRK842003OHIO WASTE GAS SCAVENGING INTERFACEK840356OHIO UNITROL II ANESTHESIA GAS MACHINEK841274BAG-TO-VENTILATOR SELECTOR VALVEK840967OHIO HEAT REFLECTING PATCHK840857OHIO 3000 INFANT WARMER SYSTEM

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Related Devices (Code: LBI)

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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