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FDA 510(k)

EXTERNAL TEST PULSE GENERATOR

K-Number: K780717 · 1978-06-30

ApplicantVitatron Medical BV
Decision Date1978-06-30
Product CodeDTC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTERNAL TEST PULSE GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Vitatron Medical BV. It received FDA 510(k) clearance on 1978-06-30 under 510(k) number K780717. 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 EXTERNAL TEST PULSE GENERATOR?

EXTERNAL TEST PULSE GENERATOR is a medical device that received FDA 510(k) clearance on 1978-06-30. The listed applicant is Vitatron Medical BV. The 510(k) number is K780717.

When did EXTERNAL TEST PULSE GENERATOR receive FDA 510(k) clearance?

EXTERNAL TEST PULSE GENERATOR received FDA 510(k) clearance on 1978-06-30, under 510(k) number K780717.

Who is the listed applicant for EXTERNAL TEST PULSE GENERATOR?

The FDA 510(k) record lists Vitatron Medical BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTERNAL TEST PULSE GENERATOR?

The FDA product code for EXTERNAL TEST PULSE GENERATOR is DTC.

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Other records listing Vitatron Medical BV 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.

K854790CERYX PACEMAKER MODELS 114, 314 & 614K844484HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEAK844483TP 1K844485CERYX6, 611, CERYX 3 311 & CERYX 1 111K840668ELECTRODE PACEMAKER, PERM & TEMPK831860GENERATOR, PULSE, PACEMAKER #532

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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.K011729SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000Dni Nevada, 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.

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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