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FDA 510(k)

OPUS MODEL 4021, VVI, 5MM UNIPOLAR

K-Number: K900461 · 1990-03-14

ApplicantEla Medical, Inc.
Decision Date1990-03-14
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OPUS MODEL 4021, VVI, 5MM UNIPOLAR 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 1990-03-14 under 510(k) number K900461. 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 OPUS MODEL 4021, VVI, 5MM UNIPOLAR?

OPUS MODEL 4021, VVI, 5MM UNIPOLAR is a medical device that received FDA 510(k) clearance on 1990-03-14. The listed applicant is Ela Medical, Inc.. The 510(k) number is K900461.

When did OPUS MODEL 4021, VVI, 5MM UNIPOLAR receive FDA 510(k) clearance?

OPUS MODEL 4021, VVI, 5MM UNIPOLAR received FDA 510(k) clearance on 1990-03-14, under 510(k) number K900461.

Who is the listed applicant for OPUS MODEL 4021, VVI, 5MM UNIPOLAR?

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 MODEL 4021, VVI, 5MM UNIPOLAR?

The FDA product code for OPUS MODEL 4021, VVI, 5MM UNIPOLAR is DXY. This falls under the Clinical Chemistry category.

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Other records listing Ela Medical, Inc. 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.

K042002SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADERK032466SPIDERVIEWK002817SYNETECK993448STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADSK000029STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADSK990727SYNEFLASH & SYNEVIEW

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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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