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FDA 510(k)

UNIFOCAL 3

K-Number: K810121 · 1981-02-23

ApplicantAmerican Pacemaker Corp.
Decision Date1981-02-23
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNIFOCAL 3 is the device name listed in this FDA 510(k) record. The listed applicant is American Pacemaker Corp.. It received FDA 510(k) clearance on 1981-02-23 under 510(k) number K810121. 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 UNIFOCAL 3?

UNIFOCAL 3 is a medical device that received FDA 510(k) clearance on 1981-02-23. The listed applicant is American Pacemaker Corp.. The 510(k) number is K810121.

When did UNIFOCAL 3 receive FDA 510(k) clearance?

UNIFOCAL 3 received FDA 510(k) clearance on 1981-02-23, under 510(k) number K810121.

Who is the listed applicant for UNIFOCAL 3?

The FDA 510(k) record lists American Pacemaker Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIFOCAL 3?

The FDA product code for UNIFOCAL 3 is DXY. This falls under the Clinical Chemistry category.

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Other records listing American Pacemaker Corp. 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.

K821791EXTERNAL PULSE GENERATOR - EV4542K812807APC IMPLANTABLE PACING LEADSK812830APC IMPLANTABLE PACING LEADK810399APC IMPLANTABEL PACING LEAD, MODEL 3264K810396APC IMPLANTABLE PACING LEAD, TINED #3262K810397APC IMPLANTABLE PACING LEAD-FLANGE #3260

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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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