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FDA 510(k)

HOMEVUE MONITORING SYS.MODEL TD 2000

K-Number: K912138 · 1992-03-19

ApplicantHomevue Health Systems, Inc.
Decision Date1992-03-19
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HOMEVUE MONITORING SYS.MODEL TD 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Homevue Health Systems, Inc.. It received FDA 510(k) clearance on 1992-03-19 under 510(k) number K912138. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOMEVUE MONITORING SYS.MODEL TD 2000?

HOMEVUE MONITORING SYS.MODEL TD 2000 is a medical device that received FDA 510(k) clearance on 1992-03-19. The listed applicant is Homevue Health Systems, Inc.. The 510(k) number is K912138.

When did HOMEVUE MONITORING SYS.MODEL TD 2000 receive FDA 510(k) clearance?

HOMEVUE MONITORING SYS.MODEL TD 2000 received FDA 510(k) clearance on 1992-03-19, under 510(k) number K912138.

Who is the listed applicant for HOMEVUE MONITORING SYS.MODEL TD 2000?

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

What is the FDA product code for HOMEVUE MONITORING SYS.MODEL TD 2000?

The FDA product code for HOMEVUE MONITORING SYS.MODEL TD 2000 is HGM.

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 Homevue Health Systems, 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.

K945807HOMEVUE WOUND MONITORING SYSTEM

Related Devices (Code: HGM)

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.

K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.K253021ANNE MaternalSibel Health, Inc.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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