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FDA 510(k)

DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1

K-Number: K973873 · 1997-12-29

ApplicantAmerican Telecare, Inc.
Decision Date1997-12-29
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 is the device name listed in this FDA 510(k) record. The listed applicant is American Telecare, Inc.. It received FDA 510(k) clearance on 1997-12-29 under 510(k) number K973873. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1?

DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 is a medical device that received FDA 510(k) clearance on 1997-12-29. The listed applicant is American Telecare, Inc.. The 510(k) number is K973873.

When did DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 receive FDA 510(k) clearance?

DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 received FDA 510(k) clearance on 1997-12-29, under 510(k) number K973873.

Who is the listed applicant for DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1?

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

What is the FDA product code for DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1?

The FDA product code for DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 is DRG.

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Other records listing American Telecare, 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.

K030222NX SYSTEMK003999AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010K993550AVIVA SYSTEM, MODEL SL1010K981533AVIVA SYSTEMS MODEL NUMBERS 1010, 2020K963678CARETONE IIK964554PERSONAL TELEMEDICINE MODULE

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Related Devices (Code: DRG)

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.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, 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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