FDA 510(k)

OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)

K-Number: K952364 · 1995-09-01

Decision Date1995-09-01

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) is the device name listed in this FDA 510(k) record. The listed applicant is Ela Medical, Inc.. It received FDA 510(k) clearance on 1995-09-01 under 510(k) number K952364. 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 - Subject to Tracking Reg..

Frequently Asked Questions

What is the OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)?

OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) is a medical device that received FDA 510(k) clearance on 1995-09-01. The listed applicant is Ela Medical, Inc.. The 510(k) number is K952364.

When did OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) receive FDA 510(k) clearance?

OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) received FDA 510(k) clearance on 1995-09-01, under 510(k) number K952364.

Who is the listed applicant for OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)?

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

What is the FDA product code for OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)?

The FDA product code for OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) is DXY. This falls under the Clinical Chemistry category.

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Other records listing Ela Medical, Inc. as applicant

K042002SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER K032466SPIDERVIEW K002817SYNETEC K993448STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS K000029STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS K990727SYNEFLASH & SYNEVIEW

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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.