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FDA 510(k)

AVIVA SYSTEM, MODEL SL1010

K-Number: K993550 · 2000-01-13

ApplicantAmerican Telecare, Inc.
Decision Date2000-01-13
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AVIVA SYSTEM, MODEL SL1010 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 2000-01-13 under 510(k) number K993550. 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 AVIVA SYSTEM, MODEL SL1010?

AVIVA SYSTEM, MODEL SL1010 is a medical device that received FDA 510(k) clearance on 2000-01-13. The listed applicant is American Telecare, Inc.. The 510(k) number is K993550.

When did AVIVA SYSTEM, MODEL SL1010 receive FDA 510(k) clearance?

AVIVA SYSTEM, MODEL SL1010 received FDA 510(k) clearance on 2000-01-13, under 510(k) number K993550.

Who is the listed applicant for AVIVA SYSTEM, MODEL SL1010?

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 AVIVA SYSTEM, MODEL SL1010?

The FDA product code for AVIVA SYSTEM, MODEL SL1010 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 1010K981533AVIVA SYSTEMS MODEL NUMBERS 1010, 2020K973873DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1K963678CARETONE 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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