FDA 510(k)

PACEMAKERS, VITATRON'S

K-Number: K760669 · 1976-11-12

Decision Date1976-11-12

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PACEMAKERS, VITATRON'S 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 K760669. 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, VITATRON'S?

PACEMAKERS, VITATRON'S 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 K760669.

When did PACEMAKERS, VITATRON'S receive FDA 510(k) clearance?

PACEMAKERS, VITATRON'S received FDA 510(k) clearance on 1976-11-12, under 510(k) number K760669.

Who is the listed applicant for PACEMAKERS, VITATRON'S?

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, VITATRON'S?

The FDA product code for PACEMAKERS, VITATRON'S 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)

K993434PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-ABiotronik, Inc.K970072OPUS S MODEL 4121 AND 4124 PACEMAKERSEla Medical, Inc.K945627PIKOS LP 01, PIKOS LP E01Biotronik, Inc.K953866MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)Medtronic Vascular K954092ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)Medtronic Vascular K953417MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORSCook Pacemaker Corp.

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.