FDA 510(k)

MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER

K-Number: K905403 · 1991-10-16

Decision Date1991-10-16

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER is the device name listed in this FDA 510(k) record. The listed applicant is Cook Pacemaker Corp.. It received FDA 510(k) clearance on 1991-10-16 under 510(k) number K905403. 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 MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER?

MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER is a medical device that received FDA 510(k) clearance on 1991-10-16. The listed applicant is Cook Pacemaker Corp.. The 510(k) number is K905403.

When did MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER receive FDA 510(k) clearance?

MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER received FDA 510(k) clearance on 1991-10-16, under 510(k) number K905403.

Who is the listed applicant for MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER?

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

What is the FDA product code for MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER?

The FDA product code for MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER is DXY. This falls under the Clinical Chemistry category.

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Other records listing Cook Pacemaker Corp. as applicant

K970690LOCKING STYLET 2 K961992NEEDLE'S EYE SNARE K953417MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS K915188MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD K863582MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)K861559SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS

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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.