FDA 510(k)

CHRONOCOR V EXTERNAL PACER, MODEL 297A

K-Number: K850822 · 1985-07-16

Decision Date1985-07-16

Product CodeDTE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CHRONOCOR V EXTERNAL PACER, MODEL 297A is the device name listed in this FDA 510(k) record. The listed applicant is Seamed Corp.. It received FDA 510(k) clearance on 1985-07-16 under 510(k) number K850822. 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 CHRONOCOR V EXTERNAL PACER, MODEL 297A?

CHRONOCOR V EXTERNAL PACER, MODEL 297A is a medical device that received FDA 510(k) clearance on 1985-07-16. The listed applicant is Seamed Corp.. The 510(k) number is K850822.

When did CHRONOCOR V EXTERNAL PACER, MODEL 297A receive FDA 510(k) clearance?

CHRONOCOR V EXTERNAL PACER, MODEL 297A received FDA 510(k) clearance on 1985-07-16, under 510(k) number K850822.

Who is the listed applicant for CHRONOCOR V EXTERNAL PACER, MODEL 297A?

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 CHRONOCOR V EXTERNAL PACER, MODEL 297A?

The FDA product code for CHRONOCOR V EXTERNAL PACER, MODEL 297A 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.