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FDA 510(k)

INFANT CARE SYSTEM

K-Number: K790137 · 1979-03-06

ApplicantNarco Air-Shields
Decision Date1979-03-06
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFANT CARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Narco Air-Shields. It received FDA 510(k) clearance on 1979-03-06 under 510(k) number K790137. 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 INFANT CARE SYSTEM?

INFANT CARE SYSTEM is a medical device that received FDA 510(k) clearance on 1979-03-06. The listed applicant is Narco Air-Shields. The 510(k) number is K790137.

When did INFANT CARE SYSTEM receive FDA 510(k) clearance?

INFANT CARE SYSTEM received FDA 510(k) clearance on 1979-03-06, under 510(k) number K790137.

Who is the listed applicant for INFANT CARE SYSTEM?

The FDA 510(k) record lists Narco Air-Shields as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFANT CARE SYSTEM?

The FDA product code for INFANT CARE SYSTEM is FMT.

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Other records listing Narco Air-Shields 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.

K820114SYSTEM V.HEART RATE/RESPIR. RATE MONIT.K810953MODEL 533 PHOTOTHERAPY UNITK810474PROBE COVERK802800NARCO AIR-SHEILDS SYS. 100 MONITOR SYSK802126ISOLETTE INCUBATOR C-100K792592AMBU UNIVERSAL SUCTION PUMP

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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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