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)

COMFOR-BOARD

K-Number: K910880 · 1991-06-06

ApplicantMedway
Decision Date1991-06-06
Product CodeKMK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COMFOR-BOARD is the device name listed in this FDA 510(k) record. The listed applicant is Medway. It received FDA 510(k) clearance on 1991-06-06 under 510(k) number K910880. The device is classified under product code KMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFOR-BOARD?

COMFOR-BOARD is a medical device that received FDA 510(k) clearance on 1991-06-06. The listed applicant is Medway. The 510(k) number is K910880.

When did COMFOR-BOARD receive FDA 510(k) clearance?

COMFOR-BOARD received FDA 510(k) clearance on 1991-06-06, under 510(k) number K910880.

Who is the listed applicant for COMFOR-BOARD?

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

What is the FDA product code for COMFOR-BOARD?

The FDA product code for COMFOR-BOARD is KMK.

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 Medway 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.

K934344HOME AMB-ALERTK931952MEDWAY OXYGEN MASKK911251FLEX-IVK911079AMB-ALERT

Related Devices (Code: KMK)

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.

K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8FInterrad Medical, Inc.K981860A P HARNESSParaworks Enterprise, Ltd.K963365MULTI-PURPOSE MEDICAL TUBE HOLDERByrd Medical Devices, Inc.K941098SECURE-SITEOp-Co Medical Products , Ltd.K943147STATLOCK CVVenetec, Inc.K943047IV START KITSSterile Concepts, Inc.

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.

↑