FDA 510(k)

UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762

K-Number: K852973 · 1986-03-31

Decision Date1986-03-31

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762 is the device name listed in this FDA 510(k) record. The listed applicant is Ela Medical, Inc.. It received FDA 510(k) clearance on 1986-03-31 under 510(k) number K852973. 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 UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762?

UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762 is a medical device that received FDA 510(k) clearance on 1986-03-31. The listed applicant is Ela Medical, Inc.. The 510(k) number is K852973.

When did UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762 receive FDA 510(k) clearance?

UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762 received FDA 510(k) clearance on 1986-03-31, under 510(k) number K852973.

Who is the listed applicant for UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762?

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

What is the FDA product code for UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762?

The FDA product code for UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762 is DXY. This falls under the Clinical Chemistry category.

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Related Devices (Code: DXY)

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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.