FDA 510(k)

ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER

K-Number: K852641 · 1986-01-14

ApplicantSorin Biomedica, Fiat, USA, Inc.

Decision Date1986-01-14

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. It received FDA 510(k) clearance on 1986-01-14 under 510(k) number K852641. 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 ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER?

ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER is a medical device that received FDA 510(k) clearance on 1986-01-14. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. The 510(k) number is K852641.

When did ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER receive FDA 510(k) clearance?

ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER received FDA 510(k) clearance on 1986-01-14, under 510(k) number K852641.

Who is the listed applicant for ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER?

The FDA 510(k) record lists Sorin Biomedica, Fiat, USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER?

The FDA product code for ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER is DXY. This falls under the Clinical Chemistry category.

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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.