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FDA 510(k)

AMB-ALERT

K-Number: K911079 · 1991-09-13

ApplicantMedway
Decision Date1991-09-13
Product CodeKMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMB-ALERT is the device name listed in this FDA 510(k) record. The listed applicant is Medway. It received FDA 510(k) clearance on 1991-09-13 under 510(k) number K911079. The device is classified under product code KMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMB-ALERT?

AMB-ALERT is a medical device that received FDA 510(k) clearance on 1991-09-13. The listed applicant is Medway. The 510(k) number is K911079.

When did AMB-ALERT receive FDA 510(k) clearance?

AMB-ALERT received FDA 510(k) clearance on 1991-09-13, under 510(k) number K911079.

Who is the listed applicant for AMB-ALERT?

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 AMB-ALERT?

The FDA product code for AMB-ALERT is KMI.

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-IVK910880COMFOR-BOARD

Related Devices (Code: KMI)

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.

K131585INTEL-GE CARE INNOVATIONS QUIETCAREIntel-Ge Care Innovations, LLCK130752DYNASENSE SYSTEMCentauri Medical, Inc.K101109VIVATRAKWireless Medcare, LLCK090138MOBILECARE MONITOR, MODEL 2100Aframe Digital, Inc.K942770ULTIMAT-SENSOR FOR BED OCCUPANCY MONITORUltimate Development Corp.K943481INFORMER PLUSMicro-Tech Medical, 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.

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