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FDA 510(k)

TELEMETRY SYSTEM XMT-1 & REC-1

K-Number: K792371 · 1980-01-31

ApplicantBurdick Corp.
Decision Date1980-01-31
Product CodeGYE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TELEMETRY SYSTEM XMT-1 & REC-1 is the device name listed in this FDA 510(k) record. The listed applicant is Burdick Corp.. It received FDA 510(k) clearance on 1980-01-31 under 510(k) number K792371. The device is classified under product code GYE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TELEMETRY SYSTEM XMT-1 & REC-1?

TELEMETRY SYSTEM XMT-1 & REC-1 is a medical device that received FDA 510(k) clearance on 1980-01-31. The listed applicant is Burdick Corp.. The 510(k) number is K792371.

When did TELEMETRY SYSTEM XMT-1 & REC-1 receive FDA 510(k) clearance?

TELEMETRY SYSTEM XMT-1 & REC-1 received FDA 510(k) clearance on 1980-01-31, under 510(k) number K792371.

Who is the listed applicant for TELEMETRY SYSTEM XMT-1 & REC-1?

The FDA 510(k) record lists Burdick Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TELEMETRY SYSTEM XMT-1 & REC-1?

The FDA product code for TELEMETRY SYSTEM XMT-1 & REC-1 is GYE.

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Other records listing Burdick Corp. 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.

K942565ALTAIR-DISC RECORDERK941351BURDICK PRO2 OXIMETERK904032ELITE II ELECTROCARDIOGRAPHK903565E560 ELECTROCARDIOGRAPHK900729NEOSERV 824K885085ERGOMED 840/ERGOMED 840L

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Related Devices (Code: GYE)

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.

K963195WIRELESS EEG RECORDING SYSTEM MODEL W32Cme Telemetrix, Inc.K970659DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVERTelediagnostic Systems, Inc.K895895MODEL 219 TELEMETRY SYSTEMMennen Medical, Inc.K891405BMS-2000 MOBILE EEG SYSTEMBuckman Co., Inc.K885328RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVERTelediagnostic Systems, Inc.K883947ISO-100 ISOLATION AMPLIFIERTelediagnostic Systems, 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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