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)

ISOLETTE INFANT INCUBATOR, MODEL C2HS

K-Number: K001242 · 2000-07-13

ApplicantHill-Rom Air-Shields
Decision Date2000-07-13
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ISOLETTE INFANT INCUBATOR, MODEL C2HS is the device name listed in this FDA 510(k) record. The listed applicant is Hill-Rom Air-Shields. It received FDA 510(k) clearance on 2000-07-13 under 510(k) number K001242. 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 ISOLETTE INFANT INCUBATOR, MODEL C2HS?

ISOLETTE INFANT INCUBATOR, MODEL C2HS is a medical device that received FDA 510(k) clearance on 2000-07-13. The listed applicant is Hill-Rom Air-Shields. The 510(k) number is K001242.

When did ISOLETTE INFANT INCUBATOR, MODEL C2HS receive FDA 510(k) clearance?

ISOLETTE INFANT INCUBATOR, MODEL C2HS received FDA 510(k) clearance on 2000-07-13, under 510(k) number K001242.

Who is the listed applicant for ISOLETTE INFANT INCUBATOR, MODEL C2HS?

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

What is the FDA product code for ISOLETTE INFANT INCUBATOR, MODEL C2HS?

The FDA product code for ISOLETTE INFANT INCUBATOR, MODEL C2HS 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 Hill-Rom 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.

K021622HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103K003335RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMERK001019TI500 GLOBE-TROTTER TRANSPORT SYSTEMK993051VERSALET 7700 CARE CENTER, MODEL # 7700

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.

↑