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FDA 510(k)

EXIT ALARM

K-Number: K905421 · 1991-02-12

ApplicantAlertcare
Decision Date1991-02-12
Product CodeKMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EXIT ALARM is the device name listed in this FDA 510(k) record. The listed applicant is Alertcare. It received FDA 510(k) clearance on 1991-02-12 under 510(k) number K905421. 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 EXIT ALARM?

EXIT ALARM is a medical device that received FDA 510(k) clearance on 1991-02-12. The listed applicant is Alertcare. The 510(k) number is K905421.

When did EXIT ALARM receive FDA 510(k) clearance?

EXIT ALARM received FDA 510(k) clearance on 1991-02-12, under 510(k) number K905421.

Who is the listed applicant for EXIT ALARM?

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

What is the FDA product code for EXIT ALARM?

The FDA product code for EXIT ALARM is KMI.

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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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