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FDA 510(k)

OHIO 3000 INFANT WARMER SYSTEM

K-Number: K840857 · 1984-03-23

ApplicantOhio Medical Products
Decision Date1984-03-23
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OHIO 3000 INFANT WARMER SYSTEM 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 1984-03-23 under 510(k) number K840857. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OHIO 3000 INFANT WARMER SYSTEM?

OHIO 3000 INFANT WARMER SYSTEM is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Ohio Medical Products. The 510(k) number is K840857.

When did OHIO 3000 INFANT WARMER SYSTEM receive FDA 510(k) clearance?

OHIO 3000 INFANT WARMER SYSTEM received FDA 510(k) clearance on 1984-03-23, under 510(k) number K840857.

Who is the listed applicant for OHIO 3000 INFANT WARMER SYSTEM?

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 OHIO 3000 INFANT WARMER SYSTEM?

The FDA product code for OHIO 3000 INFANT WARMER SYSTEM is FMT.

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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 PATCHK840858OHIO 3300 INFANT WARMER SYSTEM

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Related Devices (Code: FMT)

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.

K243606Babyroo TN300Draeger Medical Systems, Inc.K230278Babyroo TN300Draeger Medical Systems, Inc.K213551Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc.K201628Panda iRes Warmer, Giraffe WarmerGE HealthcareK200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface CableDeroyal Industries, Inc.K191425Hydro-Temp Neonatal Skin Temperature Probe CoverDeroyal Industries, Inc.

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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