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FDA 510(k)

FIRARD II/ TDP LAMP

K-Number: K960036 · 1996-06-06

ApplicantHelio Medical Supplies, Inc.
Decision Date1996-06-06
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FIRARD II/ TDP LAMP is the device name listed in this FDA 510(k) record. The listed applicant is Helio Medical Supplies, Inc.. It received FDA 510(k) clearance on 1996-06-06 under 510(k) number K960036. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIRARD II/ TDP LAMP?

FIRARD II/ TDP LAMP is a medical device that received FDA 510(k) clearance on 1996-06-06. The listed applicant is Helio Medical Supplies, Inc.. The 510(k) number is K960036.

When did FIRARD II/ TDP LAMP receive FDA 510(k) clearance?

FIRARD II/ TDP LAMP received FDA 510(k) clearance on 1996-06-06, under 510(k) number K960036.

Who is the listed applicant for FIRARD II/ TDP LAMP?

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

What is the FDA product code for FIRARD II/ TDP LAMP?

The FDA product code for FIRARD II/ TDP LAMP is ILY.

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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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