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FDA 510(k)

EXTERNAL PACEMAKER TELECTRONICS TE200

K-Number: K852746 · 1985-09-12

ApplicantSeamed Corp.
Decision Date1985-09-12
Product CodeJOQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTERNAL PACEMAKER TELECTRONICS TE200 is the device name listed in this FDA 510(k) record. The listed applicant is Seamed Corp.. It received FDA 510(k) clearance on 1985-09-12 under 510(k) number K852746. The device is classified under product code JOQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTERNAL PACEMAKER TELECTRONICS TE200?

EXTERNAL PACEMAKER TELECTRONICS TE200 is a medical device that received FDA 510(k) clearance on 1985-09-12. The listed applicant is Seamed Corp.. The 510(k) number is K852746.

When did EXTERNAL PACEMAKER TELECTRONICS TE200 receive FDA 510(k) clearance?

EXTERNAL PACEMAKER TELECTRONICS TE200 received FDA 510(k) clearance on 1985-09-12, under 510(k) number K852746.

Who is the listed applicant for EXTERNAL PACEMAKER TELECTRONICS TE200?

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

What is the FDA product code for EXTERNAL PACEMAKER TELECTRONICS TE200?

The FDA product code for EXTERNAL PACEMAKER TELECTRONICS TE200 is JOQ.

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Other records listing Seamed 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.

K923398CPI MODEL 2215K915364CHRONOCOR VI MODEL 5012K912507CPI MODEL 2215 & SEAMED MODEL 3400K910223CPI MODEL 2215/SEAMED MODEL 3400K883930SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALYK872551SEAMED MODEL 3200

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Related Devices (Code: JOQ)

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.

K173439Bloom2 Programmable Electrophysiology StimulatorFischer MedicalK092913EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04Ep MedsystemsK072200STIMLABMicropace Pty, Ltd.K070743Z6 STIMULATORSt Cardio Technologies, LLCK041442EP-4 CLINICAL STIMUTATOREp MedsystemsK040207EP-4 CLINICAL STIMULATOREp Medsystems

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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