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)

C-200 INFANT INCUBATOR

K-Number: K822656 · 1982-10-18

ApplicantNarco Scientific
Decision Date1982-10-18
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

C-200 INFANT INCUBATOR is the device name listed in this FDA 510(k) record. The listed applicant is Narco Scientific. It received FDA 510(k) clearance on 1982-10-18 under 510(k) number K822656. 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 C-200 INFANT INCUBATOR?

C-200 INFANT INCUBATOR is a medical device that received FDA 510(k) clearance on 1982-10-18. The listed applicant is Narco Scientific. The 510(k) number is K822656.

When did C-200 INFANT INCUBATOR receive FDA 510(k) clearance?

C-200 INFANT INCUBATOR received FDA 510(k) clearance on 1982-10-18, under 510(k) number K822656.

Who is the listed applicant for C-200 INFANT INCUBATOR?

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

What is the FDA product code for C-200 INFANT INCUBATOR?

The FDA product code for C-200 INFANT 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 Narco Scientific 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.

K830338NARCOTRACE 80K831428AS 1740 INTERFACE MODULEK831429AS 191 ECG TELEMETRY MODULEK822835PZ-800 VOLUME VENTILATORK831430AIR SHIELDS AS-100 MONIORING SYS-AS105K831460AS 30/TCP MODULE

View all 30 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.

↑