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FDA 510(k)

INCUBATOR CAPE

K-Number: K040794 · 2004-06-10

ApplicantWrapped IN Comfort
Decision Date2004-06-10
Product CodeMMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INCUBATOR CAPE is the device name listed in this FDA 510(k) record. The listed applicant is Wrapped IN Comfort. It received FDA 510(k) clearance on 2004-06-10 under 510(k) number K040794. The device is classified under product code MMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INCUBATOR CAPE?

INCUBATOR CAPE is a medical device that received FDA 510(k) clearance on 2004-06-10. The listed applicant is Wrapped IN Comfort. The 510(k) number is K040794.

When did INCUBATOR CAPE receive FDA 510(k) clearance?

INCUBATOR CAPE received FDA 510(k) clearance on 2004-06-10, under 510(k) number K040794.

Who is the listed applicant for INCUBATOR CAPE?

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

What is the FDA product code for INCUBATOR CAPE?

The FDA product code for INCUBATOR CAPE is MMP.

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 Wrapped IN Comfort 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.

K043234LIGHT DRAPE

Related Devices (Code: MMP)

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.

K091178MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREENMtp Medical Technical Promotion GmbHK043234LIGHT DRAPEWrapped IN ComfortK041501GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERSGuangzhou Fortunique , Ltd.K032065MEDLINE BAND BAGS AND EQUIPMENT COVERSMedline Industries, Inc.K023540SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09ValumedK014239MEDSURG EQUIPMENT COVERSInternational Medsurg Connection

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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