FDA 510(k)

PRIMA-UNIPOLAR CARDIAC PULSE GENERAT

K-Number: K832914 · 1983-11-14

Decision Date1983-11-14

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PRIMA-UNIPOLAR CARDIAC PULSE GENERAT is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1983-11-14 under 510(k) number K832914. 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 PRIMA-UNIPOLAR CARDIAC PULSE GENERAT?

PRIMA-UNIPOLAR CARDIAC PULSE GENERAT is a medical device that received FDA 510(k) clearance on 1983-11-14. The listed applicant is Intermedics, Inc.. The 510(k) number is K832914.

When did PRIMA-UNIPOLAR CARDIAC PULSE GENERAT receive FDA 510(k) clearance?

PRIMA-UNIPOLAR CARDIAC PULSE GENERAT received FDA 510(k) clearance on 1983-11-14, under 510(k) number K832914.

Who is the listed applicant for PRIMA-UNIPOLAR CARDIAC PULSE GENERAT?

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

What is the FDA product code for PRIMA-UNIPOLAR CARDIAC PULSE GENERAT?

The FDA product code for PRIMA-UNIPOLAR CARDIAC PULSE GENERAT is DXY. This falls under the Clinical Chemistry category.

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Other records listing Intermedics, Inc. as applicant

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.