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FDA 510(k)

MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET

K-Number: K884280 · 1988-12-22

ApplicantGempco, Inc.
Decision Date1988-12-22
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET is the device name listed in this FDA 510(k) record. The listed applicant is Gempco, Inc.. It received FDA 510(k) clearance on 1988-12-22 under 510(k) number K884280. 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 MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET?

MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET is a medical device that received FDA 510(k) clearance on 1988-12-22. The listed applicant is Gempco, Inc.. The 510(k) number is K884280.

When did MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET receive FDA 510(k) clearance?

MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET received FDA 510(k) clearance on 1988-12-22, under 510(k) number K884280.

Who is the listed applicant for MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET?

The FDA 510(k) record lists Gempco, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET?

The FDA product code for MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET is FMT.

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 Gempco, Inc. 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.

K884283MODEL WC-107 MOBILE NEWBORN BEDK884285MODEL WC-115 MOBILE BASSINETK881713SPECIAL PROCEDURES BASE UNIT MODEL 500

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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