FDA 510(k)

SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM

K-Number: K851365 · 1985-12-03

ApplicantSorin Biomedica, Fiat, USA, Inc.

Decision Date1985-12-03

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM 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 1985-12-03 under 510(k) number K851365. 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 SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM?

SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM is a medical device that received FDA 510(k) clearance on 1985-12-03. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. The 510(k) number is K851365.

When did SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM receive FDA 510(k) clearance?

SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM received FDA 510(k) clearance on 1985-12-03, under 510(k) number K851365.

Who is the listed applicant for SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM?

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 SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM?

The FDA product code for SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM is DXY. This falls under the Clinical Chemistry category.

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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.