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FDA 510(k)

PACE-PULSE/COMPUTRAC

K-Number: K800782 · 1980-05-28

ApplicantBib, Inc.
Decision Date1980-05-28
Product CodeKRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACE-PULSE/COMPUTRAC is the device name listed in this FDA 510(k) record. The listed applicant is Bib, Inc.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K800782. The device is classified under product code KRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACE-PULSE/COMPUTRAC?

PACE-PULSE/COMPUTRAC is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Bib, Inc.. The 510(k) number is K800782.

When did PACE-PULSE/COMPUTRAC receive FDA 510(k) clearance?

PACE-PULSE/COMPUTRAC received FDA 510(k) clearance on 1980-05-28, under 510(k) number K800782.

Who is the listed applicant for PACE-PULSE/COMPUTRAC?

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

What is the FDA product code for PACE-PULSE/COMPUTRAC?

The FDA product code for PACE-PULSE/COMPUTRAC is KRE.

Related Clinical Trials

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.

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Other records listing Bib, 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.

K830916VITA/TRAC 4 FUNCTION VITAL SIGN MONITORK801389BARO/TRAC II & VITA/TRAC, VITAL SIGN MONK801366DISPOSABLE TEMPERATURE PROBE COVERK800596VITA/TRAC 4-FUNCTION VITAL SIGN MONITOR

Related Devices (Code: KRE)

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.

K110693PACEART OPTIMA SYSTEM SOFTWAREMedtronic, Inc.K072950CYGNUS 12 LEAD ECG MODULECygnus, LLCK032926EKG SPEAKSMedtronic VascularK922742HPM 40 HEART PACEMAKER MONITORBiotronik, GmbH & Co.K915632PACEART CPTS-86/12Paceart, Inc.K895535PACEVIEWMicromedical

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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