Tempo and Temp H20

Q: When was Tempo and Temp H20 cleared by the FDA?

Tempo and Temp H20 (K973748) received a 510(k) decision of Substantially Equivalent on March 10, 1998, 160 days after the submission was received.

Q: What is the product code of K973748?

The FDA product code is LGZ – Warmer, Thermal, Infusion Fluid, a Class II (moderate risk) device regulated under 21 CFR 880.5725.

FDA 510(k) K973748 · Smith

Substantially Equivalent

510(k) numberK973748

Submission

Device name: Tempo and Temp H20
Applicant: Smith
Crofton, MD, US
Received: October 1, 1997
Decision date: March 10, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: LGZ – Warmer, Thermal, Infusion Fluid
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.5725
Specialty: General Hospital

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More from Mac Medical, Inc.

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K972123	Protective Restraint Models #302,440,750,850,AND905FMQ · Traditional	07/25/1997SE
K971092	Qa-EsGEI · Traditional	04/23/1997SE
K970555	IL0292 DP EchoportEWO · Traditional	03/17/1997SE

Questions and answers

When was Tempo and Temp H20 cleared by the FDA?

Tempo and Temp H20 (K973748) received a 510(k) decision of Substantially Equivalent on March 10, 1998, 160 days after the submission was received.

What is the product code of K973748?

The FDA product code is LGZ – Warmer, Thermal, Infusion Fluid, a Class II (moderate risk) device regulated under 21 CFR 880.5725.