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FDA 510(k)

COMMAND ULTRA II

K-Number: K830382 · 1983-03-17

ApplicantCardiac Pacemakers, Inc.
Decision Date1983-03-17
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COMMAND ULTRA II is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Pacemakers, Inc.. It received FDA 510(k) clearance on 1983-03-17 under 510(k) number K830382. 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 COMMAND ULTRA II?

COMMAND ULTRA II is a medical device that received FDA 510(k) clearance on 1983-03-17. The listed applicant is Cardiac Pacemakers, Inc.. The 510(k) number is K830382.

When did COMMAND ULTRA II receive FDA 510(k) clearance?

COMMAND ULTRA II received FDA 510(k) clearance on 1983-03-17, under 510(k) number K830382.

Who is the listed applicant for COMMAND ULTRA II?

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

What is the FDA product code for COMMAND ULTRA II?

The FDA product code for COMMAND ULTRA II is DXY. This falls under the Clinical Chemistry category.

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Other records listing Cardiac Pacemakers, 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.

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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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