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FDA 510(k)

POLYTEL(R) APT MODEL: PWA-08-01

K-Number: K100524 · 2010-05-24

ApplicantPolymap Wireless, LLC
Decision Date2010-05-24
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POLYTEL(R) APT MODEL: PWA-08-01 is the device name listed in this FDA 510(k) record. The listed applicant is Polymap Wireless, LLC. It received FDA 510(k) clearance on 2010-05-24 under 510(k) number K100524. 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 POLYTEL(R) APT MODEL: PWA-08-01?

POLYTEL(R) APT MODEL: PWA-08-01 is a medical device that received FDA 510(k) clearance on 2010-05-24. The listed applicant is Polymap Wireless, LLC. The 510(k) number is K100524.

When did POLYTEL(R) APT MODEL: PWA-08-01 receive FDA 510(k) clearance?

POLYTEL(R) APT MODEL: PWA-08-01 received FDA 510(k) clearance on 2010-05-24, under 510(k) number K100524.

Who is the listed applicant for POLYTEL(R) APT MODEL: PWA-08-01?

The FDA 510(k) record lists Polymap Wireless, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYTEL(R) APT MODEL: PWA-08-01?

The FDA product code for POLYTEL(R) APT MODEL: PWA-08-01 is DRG.

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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

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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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