FDA 510(k)

OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE

K-Number: K903186 · 1991-01-18

ApplicantTelectronics Pacing Systems, Inc.

Decision Date1991-01-18

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics Pacing Systems, Inc.. It received FDA 510(k) clearance on 1991-01-18 under 510(k) number K903186. 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 OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE?

OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE is a medical device that received FDA 510(k) clearance on 1991-01-18. The listed applicant is Telectronics Pacing Systems, Inc.. The 510(k) number is K903186.

When did OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE receive FDA 510(k) clearance?

OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE received FDA 510(k) clearance on 1991-01-18, under 510(k) number K903186.

Who is the listed applicant for OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE?

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

What is the FDA product code for OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE?

The FDA product code for OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE is DXY. This falls under the Clinical Chemistry category.

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Other records listing Telectronics Pacing Systems, 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

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