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FDA 510(k)

SORIN PULSE GENERATOR, MODEL #LIT-214

K-Number: K801640 · 1980-10-03

ApplicantBentley Laboratories, Inc.
Decision Date1980-10-03
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SORIN PULSE GENERATOR, MODEL #LIT-214 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 1980-10-03 under 510(k) number K801640. 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?

SORIN PULSE GENERATOR, MODEL #LIT-214 is a medical device that received FDA 510(k) clearance on 1980-10-03. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K801640.

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

SORIN PULSE GENERATOR, MODEL #LIT-214 received FDA 510(k) clearance on 1980-10-03, under 510(k) number K801640.

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

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?

The FDA product code for SORIN PULSE GENERATOR, MODEL #LIT-214 is DXY. This falls under the Clinical Chemistry category.

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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.

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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.

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