FDA 510(k)

QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.

K-Number: K874394 · 1987-11-23

Decision Date1987-11-23

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA. is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1987-11-23 under 510(k) number K874394. 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 QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.?

QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA. is a medical device that received FDA 510(k) clearance on 1987-11-23. The listed applicant is Intermedics, Inc.. The 510(k) number is K874394.

When did QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA. receive FDA 510(k) clearance?

QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA. received FDA 510(k) clearance on 1987-11-23, under 510(k) number K874394.

Who is the listed applicant for QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.?

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 QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.?

The FDA product code for QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA. 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.