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FDA 510(k)

COMPUPACE, 524-01 PACER SYSTEM COMPUTER

K-Number: K801055 · 1980-10-31

ApplicantIntermedics, Inc.
Decision Date1980-10-31
Product CodeDTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COMPUPACE, 524-01 PACER SYSTEM COMPUTER is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K801055. 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 COMPUPACE, 524-01 PACER SYSTEM COMPUTER?

COMPUPACE, 524-01 PACER SYSTEM COMPUTER is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Intermedics, Inc.. The 510(k) number is K801055.

When did COMPUPACE, 524-01 PACER SYSTEM COMPUTER receive FDA 510(k) clearance?

COMPUPACE, 524-01 PACER SYSTEM COMPUTER received FDA 510(k) clearance on 1980-10-31, under 510(k) number K801055.

Who is the listed applicant for COMPUPACE, 524-01 PACER SYSTEM COMPUTER?

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

What is the FDA product code for COMPUPACE, 524-01 PACER SYSTEM COMPUTER?

The FDA product code for COMPUPACE, 524-01 PACER SYSTEM COMPUTER is DTE.

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Other records listing Intermedics, Inc. 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.

K954610MODEL 430-07 ENDOCARDIAL PACING LEADK955122INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADK962174BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)K955550CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEADK960281IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORYK954719INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

View all 211 devices →

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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