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FDA 510(k)

CARDIAC PACEMAKER S6001

K-Number: K772009 · 1977-11-28

ApplicantVitatron Medical BV
Decision Date1977-11-28
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAC PACEMAKER S6001 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 1977-11-28 under 510(k) number K772009. 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 CARDIAC PACEMAKER S6001?

CARDIAC PACEMAKER S6001 is a medical device that received FDA 510(k) clearance on 1977-11-28. The listed applicant is Vitatron Medical BV. The 510(k) number is K772009.

When did CARDIAC PACEMAKER S6001 receive FDA 510(k) clearance?

CARDIAC PACEMAKER S6001 received FDA 510(k) clearance on 1977-11-28, under 510(k) number K772009.

Who is the listed applicant for CARDIAC PACEMAKER S6001?

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 CARDIAC PACEMAKER S6001?

The FDA product code for CARDIAC PACEMAKER S6001 is DXY. This falls under the Clinical Chemistry category.

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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: DXY)

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.

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 VascularK954092ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)Medtronic VascularK953417MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORSCook Pacemaker Corp.

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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