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FDA 510(k)

UNIVERSAL TEMP. PACING ELECT. #080-10000

K-Number: K801800 · 1980-10-23

ApplicantMedical Testing System, Inc.
Decision Date1980-10-23
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL TEMP. PACING ELECT. #080-10000 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Testing System, Inc.. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K801800. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL TEMP. PACING ELECT. #080-10000?

UNIVERSAL TEMP. PACING ELECT. #080-10000 is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Medical Testing System, Inc.. The 510(k) number is K801800.

When did UNIVERSAL TEMP. PACING ELECT. #080-10000 receive FDA 510(k) clearance?

UNIVERSAL TEMP. PACING ELECT. #080-10000 received FDA 510(k) clearance on 1980-10-23, under 510(k) number K801800.

Who is the listed applicant for UNIVERSAL TEMP. PACING ELECT. #080-10000?

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

What is the FDA product code for UNIVERSAL TEMP. PACING ELECT. #080-10000?

The FDA product code for UNIVERSAL TEMP. PACING ELECT. #080-10000 is LDF.

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 Medical Testing System, 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.

K801802ELECTROMAGNETIC BLOOD & ARTERIAL GAUGEK801799ATRIAL/VENTRICULAR SEQENTIAL #080-20000K791797MTS CATHETER ADAPTER FOR GUIDANCE ENTRYK770641MINI-CONER TM

Related Devices (Code: LDF)

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.

K252042Sync AV II Temporary Pacing CatheterSwift Sync, Inc.K242863Bioptimal Bipolar Pacing CatheterBioptimal International Pte. , Ltd.K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)C.R. Bard, Inc.K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,C.R. Bard, Inc.K241199Rotatable Connector (5944RL)Shenzhen Launch Electrical Co., Ltd.K242705Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)Medtronic, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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