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FDA 510(k)

TECNOL TELEMETRY UNIT POUCH

K-Number: K802849 · 1980-12-16

ApplicantTecnol New Jersey Wound Care, Inc.
Decision Date1980-12-16
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TECNOL TELEMETRY UNIT POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Tecnol New Jersey Wound Care, Inc.. It received FDA 510(k) clearance on 1980-12-16 under 510(k) number K802849. 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 TECNOL TELEMETRY UNIT POUCH?

TECNOL TELEMETRY UNIT POUCH is a medical device that received FDA 510(k) clearance on 1980-12-16. The listed applicant is Tecnol New Jersey Wound Care, Inc.. The 510(k) number is K802849.

When did TECNOL TELEMETRY UNIT POUCH receive FDA 510(k) clearance?

TECNOL TELEMETRY UNIT POUCH received FDA 510(k) clearance on 1980-12-16, under 510(k) number K802849.

Who is the listed applicant for TECNOL TELEMETRY UNIT POUCH?

The FDA 510(k) record lists Tecnol New Jersey Wound Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TECNOL TELEMETRY UNIT POUCH?

The FDA product code for TECNOL TELEMETRY UNIT POUCH is DRG.

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Other records listing Tecnol New Jersey Wound Care, 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.

K913043MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKSK911891FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASKK911907FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VISK896193TECNOL LAZER(TM) SURGICAL MASKK894205TECNOL SILK STRIPK893702TECNOL GAITERS PRODUCT NUMBER 47725-010

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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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