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FDA 510(k)

THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300

K-Number: K073363 · 2008-03-20

ApplicantPaladin Biomedical Corporation
Decision Date2008-03-20
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 is the device name listed in this FDA 510(k) record. The listed applicant is Paladin Biomedical Corporation. It received FDA 510(k) clearance on 2008-03-20 under 510(k) number K073363. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300?

THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 is a medical device that received FDA 510(k) clearance on 2008-03-20. The listed applicant is Paladin Biomedical Corporation. The 510(k) number is K073363.

When did THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 receive FDA 510(k) clearance?

THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 received FDA 510(k) clearance on 2008-03-20, under 510(k) number K073363.

Who is the listed applicant for THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300?

The FDA 510(k) record lists Paladin Biomedical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300?

The FDA product code for THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 is LGZ.

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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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