FDA 510(k)

SEAMED, #540 - SIEMENS, #146F TELECTRO

K-Number: K820570 · 1982-06-03

Decision Date1982-06-03

Product CodeDTE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SEAMED, #540 - SIEMENS, #146F TELECTRO is the device name listed in this FDA 510(k) record. The listed applicant is Seamed Corp.. It received FDA 510(k) clearance on 1982-06-03 under 510(k) number K820570. 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 SEAMED, #540 - SIEMENS, #146F TELECTRO?

SEAMED, #540 - SIEMENS, #146F TELECTRO is a medical device that received FDA 510(k) clearance on 1982-06-03. The listed applicant is Seamed Corp.. The 510(k) number is K820570.

When did SEAMED, #540 - SIEMENS, #146F TELECTRO receive FDA 510(k) clearance?

SEAMED, #540 - SIEMENS, #146F TELECTRO received FDA 510(k) clearance on 1982-06-03, under 510(k) number K820570.

Who is the listed applicant for SEAMED, #540 - SIEMENS, #146F TELECTRO?

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 SEAMED, #540 - SIEMENS, #146F TELECTRO?

The FDA product code for SEAMED, #540 - SIEMENS, #146F TELECTRO is DTE.

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Other records listing Seamed Corp. as applicant

K923398CPI MODEL 2215 K915364CHRONOCOR VI MODEL 5012 K912507CPI MODEL 2215 & SEAMED MODEL 3400 K910223CPI MODEL 2215/SEAMED MODEL 3400 K883930SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY K872551SEAMED MODEL 3200

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Related Devices (Code: DTE)

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.