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FDA 510(k)

ASCOM MOBILE MONITORING GATEWAY (MMG)

K-Number: K111215 · 2011-07-05

ApplicantAscom (Sweden) AB
Decision Date2011-07-05
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASCOM MOBILE MONITORING GATEWAY (MMG) is the device name listed in this FDA 510(k) record. The listed applicant is Ascom (Sweden) AB. It received FDA 510(k) clearance on 2011-07-05 under 510(k) number K111215. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASCOM MOBILE MONITORING GATEWAY (MMG)?

ASCOM MOBILE MONITORING GATEWAY (MMG) is a medical device that received FDA 510(k) clearance on 2011-07-05. The listed applicant is Ascom (Sweden) AB. The 510(k) number is K111215.

When did ASCOM MOBILE MONITORING GATEWAY (MMG) receive FDA 510(k) clearance?

ASCOM MOBILE MONITORING GATEWAY (MMG) received FDA 510(k) clearance on 2011-07-05, under 510(k) number K111215.

Who is the listed applicant for ASCOM MOBILE MONITORING GATEWAY (MMG)?

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

What is the FDA product code for ASCOM MOBILE MONITORING GATEWAY (MMG)?

The FDA product code for ASCOM MOBILE MONITORING GATEWAY (MMG) is MSX.

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 Ascom (Sweden) AB 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.

K180566Unite Connect for Clinical Systems

Related Devices (Code: MSX)

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.

K261287Digistat CareAscom Ums Srl UnipersonaleK260211Dashboard (P007000)Hill-Rom, Inc.K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbHK243270TigerConnect Alarm ManagementTigerconnectK242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.

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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