Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MODEL WC-115 MOBILE BASSINET

K-Number: K884285 · 1988-12-22

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

Device Summary

MODEL WC-115 MOBILE BASSINET 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 K884285. 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-115 MOBILE BASSINET?

MODEL WC-115 MOBILE BASSINET 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 K884285.

When did MODEL WC-115 MOBILE BASSINET receive FDA 510(k) clearance?

MODEL WC-115 MOBILE BASSINET received FDA 510(k) clearance on 1988-12-22, under 510(k) number K884285.

Who is the listed applicant for MODEL WC-115 MOBILE BASSINET?

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-115 MOBILE BASSINET?

The FDA product code for MODEL WC-115 MOBILE BASSINET 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 BEDK884280MODEL WC-102 NEWBORN BED & EQUIPMENT CABINETK881713SPECIAL 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.

↑