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FDA 510(k)

MOBILECARE MONITOR, MODEL 2100

K-Number: K090138 · 2009-04-24

ApplicantAframe Digital, Inc.
Decision Date2009-04-24
Product CodeKMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MOBILECARE MONITOR, MODEL 2100 is the device name listed in this FDA 510(k) record. The listed applicant is Aframe Digital, Inc.. It received FDA 510(k) clearance on 2009-04-24 under 510(k) number K090138. 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 MOBILECARE MONITOR, MODEL 2100?

MOBILECARE MONITOR, MODEL 2100 is a medical device that received FDA 510(k) clearance on 2009-04-24. The listed applicant is Aframe Digital, Inc.. The 510(k) number is K090138.

When did MOBILECARE MONITOR, MODEL 2100 receive FDA 510(k) clearance?

MOBILECARE MONITOR, MODEL 2100 received FDA 510(k) clearance on 2009-04-24, under 510(k) number K090138.

Who is the listed applicant for MOBILECARE MONITOR, MODEL 2100?

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

What is the FDA product code for MOBILECARE MONITOR, MODEL 2100?

The FDA product code for MOBILECARE MONITOR, MODEL 2100 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.

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Other records listing Aframe Digital, Inc. 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.

K122333MOBILECARE MONITOR

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, LLCK942770ULTIMAT-SENSOR FOR BED OCCUPANCY MONITORUltimate Development Corp.K943481INFORMER PLUSMicro-Tech Medical, Inc.K933552PM-PAGERHill Engineering

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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