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FDA 510(k)

INCUBATOR 8000 IC

K-Number: K913394 · 1991-11-22

ApplicantDragerwerk AG
Decision Date1991-11-22
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INCUBATOR 8000 IC is the device name listed in this FDA 510(k) record. The listed applicant is Dragerwerk AG. It received FDA 510(k) clearance on 1991-11-22 under 510(k) number K913394. 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 INCUBATOR 8000 IC?

INCUBATOR 8000 IC is a medical device that received FDA 510(k) clearance on 1991-11-22. The listed applicant is Dragerwerk AG. The 510(k) number is K913394.

When did INCUBATOR 8000 IC receive FDA 510(k) clearance?

INCUBATOR 8000 IC received FDA 510(k) clearance on 1991-11-22, under 510(k) number K913394.

Who is the listed applicant for INCUBATOR 8000 IC?

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

What is the FDA product code for INCUBATOR 8000 IC?

The FDA product code for INCUBATOR 8000 IC 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 Dragerwerk AG 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.

K900752INCUBATOR 8000K800631OXYMETER

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.

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