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FDA 510(k)

AXICARE BREAST SHELL

K-Number: K811364 · 1981-08-03

ApplicantNeonatal Corp.
Decision Date1981-08-03
Product CodeHFS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AXICARE BREAST SHELL is the device name listed in this FDA 510(k) record. The listed applicant is Neonatal Corp.. It received FDA 510(k) clearance on 1981-08-03 under 510(k) number K811364. The device is classified under product code HFS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXICARE BREAST SHELL?

AXICARE BREAST SHELL is a medical device that received FDA 510(k) clearance on 1981-08-03. The listed applicant is Neonatal Corp.. The 510(k) number is K811364.

When did AXICARE BREAST SHELL receive FDA 510(k) clearance?

AXICARE BREAST SHELL received FDA 510(k) clearance on 1981-08-03, under 510(k) number K811364.

Who is the listed applicant for AXICARE BREAST SHELL?

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

What is the FDA product code for AXICARE BREAST SHELL?

The FDA product code for AXICARE BREAST SHELL is HFS.

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 Neonatal Corp. 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.

K811707AXICUT DISPOSABLE SCALPELK811403AXICARE BREAST PUMP MODEL

Related Devices (Code: HFS)

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.

K944117AVENT NIPPLE SHIELDAvent America, Inc.K944177BREAST SHELLO'Donnell, Byrne & WilliamsK935341COMFORT PLUS BREAST SHELLSMarshall Baby ProductsK935340COMFORT PLUS NIPPLE SHIELDSMarshall Baby ProductsK930238BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDSProlac, Inc.K923577BREAST SHELLSMedela, Inc.

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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