FDA 510(k)

SORIN PULSE GENERATOR MODEL # LIT 214 H

K-Number: K792565 · 1980-02-05

Decision Date1980-02-05

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SORIN PULSE GENERATOR MODEL # LIT 214 H is the device name listed in this FDA 510(k) record. The listed applicant is Bentley Laboratories, Inc.. It received FDA 510(k) clearance on 1980-02-05 under 510(k) number K792565. 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 PULSE GENERATOR MODEL # LIT 214 H?

SORIN PULSE GENERATOR MODEL # LIT 214 H is a medical device that received FDA 510(k) clearance on 1980-02-05. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K792565.

When did SORIN PULSE GENERATOR MODEL # LIT 214 H receive FDA 510(k) clearance?

SORIN PULSE GENERATOR MODEL # LIT 214 H received FDA 510(k) clearance on 1980-02-05, under 510(k) number K792565.

Who is the listed applicant for SORIN PULSE GENERATOR MODEL # LIT 214 H?

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

What is the FDA product code for SORIN PULSE GENERATOR MODEL # LIT 214 H?

The FDA product code for SORIN PULSE GENERATOR MODEL # LIT 214 H 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.