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FDA 510(k)

SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000

K-Number: K011729 · 2001-08-30

ApplicantDni Nevada, Inc.
Decision Date2001-08-30
Product CodeDTC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 is the device name listed in this FDA 510(k) record. The listed applicant is Dni Nevada, Inc.. It received FDA 510(k) clearance on 2001-08-30 under 510(k) number K011729. The device is classified under product code DTC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000?

SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 is a medical device that received FDA 510(k) clearance on 2001-08-30. The listed applicant is Dni Nevada, Inc.. The 510(k) number is K011729.

When did SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 receive FDA 510(k) clearance?

SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 received FDA 510(k) clearance on 2001-08-30, under 510(k) number K011729.

Who is the listed applicant for SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000?

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

What is the FDA product code for SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000?

The FDA product code for SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 is DTC.

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Related Devices (Code: DTC)

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.

K170815PSA CableBoston Scientific CorporationK083674PK-141 PATIENT CABLEBiotronik, Inc.K002497MODEL 4810 ANALYZER OUTPUT ADAPTERPace MedicalK961582EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100North American Technical Services Corp.K903966EXTERNAL PACEMAKER ANALYZER MODEL PMA-1Bio-Tek Instruments, Inc.K910595MODEL 5311B A-V PACING SYSTEM ANALYZERMedtronic Vascular

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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