Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AVIVA SYSTEMS MODEL NUMBERS 1010, 2020

K-Number: K981533 · 1998-07-15

ApplicantAmerican Telecare, Inc.
Decision Date1998-07-15
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AVIVA SYSTEMS MODEL NUMBERS 1010, 2020 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 1998-07-15 under 510(k) number K981533. 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 SYSTEMS MODEL NUMBERS 1010, 2020?

AVIVA SYSTEMS MODEL NUMBERS 1010, 2020 is a medical device that received FDA 510(k) clearance on 1998-07-15. The listed applicant is American Telecare, Inc.. The 510(k) number is K981533.

When did AVIVA SYSTEMS MODEL NUMBERS 1010, 2020 receive FDA 510(k) clearance?

AVIVA SYSTEMS MODEL NUMBERS 1010, 2020 received FDA 510(k) clearance on 1998-07-15, under 510(k) number K981533.

Who is the listed applicant for AVIVA SYSTEMS MODEL NUMBERS 1010, 2020?

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 SYSTEMS MODEL NUMBERS 1010, 2020?

The FDA product code for AVIVA SYSTEMS MODEL NUMBERS 1010, 2020 is DRG.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SL1010K973873DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1K963678CARETONE IIK964554PERSONAL TELEMEDICINE MODULE

View all 9 devices →

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.

↑