FDA 510(k)

PACEMAKERS, VITATRONS (SERIES 3000)

K-Number: K760671 · 1976-11-12

Decision Date1976-11-12

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PACEMAKERS, VITATRONS (SERIES 3000) 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 1976-11-12 under 510(k) number K760671. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACEMAKERS, VITATRONS (SERIES 3000)?

PACEMAKERS, VITATRONS (SERIES 3000) is a medical device that received FDA 510(k) clearance on 1976-11-12. The listed applicant is Vitatron Medical BV. The 510(k) number is K760671.

When did PACEMAKERS, VITATRONS (SERIES 3000) receive FDA 510(k) clearance?

PACEMAKERS, VITATRONS (SERIES 3000) received FDA 510(k) clearance on 1976-11-12, under 510(k) number K760671.

Who is the listed applicant for PACEMAKERS, VITATRONS (SERIES 3000)?

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 PACEMAKERS, VITATRONS (SERIES 3000)?

The FDA product code for PACEMAKERS, VITATRONS (SERIES 3000) is DXY. This falls under the Clinical Chemistry category.

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Other records listing Vitatron Medical BV as applicant

K854790CERYX PACEMAKER MODELS 114, 314 & 614 K844484HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA K844485CERYX6, 611, CERYX 3 311 & CERYX 1 111 K844483TP 1 K840668ELECTRODE PACEMAKER, PERM & TEMP K831860GENERATOR, PULSE, PACEMAKER #532

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Related Devices (Code: DXY)

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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.