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FDA 510(k)

K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE

K-Number: K924324 · 1993-11-12

ApplicantK-1 Medical Products, Inc.
Decision Date1993-11-12
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE is the device name listed in this FDA 510(k) record. The listed applicant is K-1 Medical Products, Inc.. It received FDA 510(k) clearance on 1993-11-12 under 510(k) number K924324. 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 K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE?

K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE is a medical device that received FDA 510(k) clearance on 1993-11-12. The listed applicant is K-1 Medical Products, Inc.. The 510(k) number is K924324.

When did K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE receive FDA 510(k) clearance?

K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE received FDA 510(k) clearance on 1993-11-12, under 510(k) number K924324.

Who is the listed applicant for K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE?

The FDA 510(k) record lists K-1 Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE?

The FDA product code for K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE 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 K-1 Medical Products, 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.

K895550K-1 INFANT TRANSPORT SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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