FDA 510(k)

THINLITH II PULSE GNEERATOR MODEL 227-05

K-Number: K810386 · 1981-03-13

Decision Date1981-03-13

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

THINLITH II PULSE GNEERATOR MODEL 227-05 is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1981-03-13 under 510(k) number K810386. 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 THINLITH II PULSE GNEERATOR MODEL 227-05?

THINLITH II PULSE GNEERATOR MODEL 227-05 is a medical device that received FDA 510(k) clearance on 1981-03-13. The listed applicant is Intermedics, Inc.. The 510(k) number is K810386.

When did THINLITH II PULSE GNEERATOR MODEL 227-05 receive FDA 510(k) clearance?

THINLITH II PULSE GNEERATOR MODEL 227-05 received FDA 510(k) clearance on 1981-03-13, under 510(k) number K810386.

Who is the listed applicant for THINLITH II PULSE GNEERATOR MODEL 227-05?

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

What is the FDA product code for THINLITH II PULSE GNEERATOR MODEL 227-05?

The FDA product code for THINLITH II PULSE GNEERATOR MODEL 227-05 is DXY. This falls under the Clinical Chemistry category.

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Related Devices (Code: DXY)

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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.