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FDA 510(k)

EXTERNAL, TEMP. PORTABLE CARDIAC GENER

K-Number: K801953 · 1980-10-23

ApplicantTelectronics, Inc.
Decision Date1980-10-23
Product CodeDTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTERNAL, TEMP. PORTABLE CARDIAC GENER is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K801953. The device is classified under product code DTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTERNAL, TEMP. PORTABLE CARDIAC GENER?

EXTERNAL, TEMP. PORTABLE CARDIAC GENER is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Telectronics, Inc.. The 510(k) number is K801953.

When did EXTERNAL, TEMP. PORTABLE CARDIAC GENER receive FDA 510(k) clearance?

EXTERNAL, TEMP. PORTABLE CARDIAC GENER received FDA 510(k) clearance on 1980-10-23, under 510(k) number K801953.

Who is the listed applicant for EXTERNAL, TEMP. PORTABLE CARDIAC GENER?

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

What is the FDA product code for EXTERNAL, TEMP. PORTABLE CARDIAC GENER?

The FDA product code for EXTERNAL, TEMP. PORTABLE CARDIAC GENER is DTE.

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Other records listing Telectronics, Inc. as applicant

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Related Devices (Code: DTE)

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.

K241781Solo Pace ControlSolo Pace, Inc.K232721Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K201011Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K190825Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K182839Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K181973Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, 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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