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)

NEOCARE BABY-CONTROLLED INCUBATOR

K-Number: K813238 · 1982-01-22

ApplicantVickers America Medical Corp.
Decision Date1982-01-22
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEOCARE BABY-CONTROLLED INCUBATOR is the device name listed in this FDA 510(k) record. The listed applicant is Vickers America Medical Corp.. It received FDA 510(k) clearance on 1982-01-22 under 510(k) number K813238. The device is classified under product code FMZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOCARE BABY-CONTROLLED INCUBATOR?

NEOCARE BABY-CONTROLLED INCUBATOR is a medical device that received FDA 510(k) clearance on 1982-01-22. The listed applicant is Vickers America Medical Corp.. The 510(k) number is K813238.

When did NEOCARE BABY-CONTROLLED INCUBATOR receive FDA 510(k) clearance?

NEOCARE BABY-CONTROLLED INCUBATOR received FDA 510(k) clearance on 1982-01-22, under 510(k) number K813238.

Who is the listed applicant for NEOCARE BABY-CONTROLLED INCUBATOR?

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

What is the FDA product code for NEOCARE BABY-CONTROLLED INCUBATOR?

The FDA product code for NEOCARE BABY-CONTROLLED INCUBATOR is FMZ.

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 Vickers America Medical Corp. 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.

K840823TREONIC C30K831838LABORATORY DATA MGMT SYSTEM SDMSK830748RESUSCITAIREK830936TREONIC IP5K813239OXYGENAIRE NURING INCUBATORK811865VMA PEDIATRIC APNEA MATTRESS

View all 22 devices →

Related Devices (Code: FMZ)

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.

K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc.K251619Babyleo TN500Drägerwerk AG & Co. KGaAK251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc.K243437mOm Essential Incubator (ME1)Mom Incubators LimitedK213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc.K190494Infant IncubatorNingbo David Medical Device Co., Ltd.

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.

↑