Controlled Temperature Cabinet System

FDA 510(k) K973747 · Smith

Substantially Equivalent

510(k) numberK973747

Submission

Device name: Controlled Temperature Cabinet System
Applicant: Smith
Crofton, MD, US
Received: October 1, 1997
Decision date: May 7, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

No product code recorded.

Other 510(k)s with product code LDQ

510(k)	Device	Applicant	Decision
K993797	EC-7701 Fluid Warming CabinetLDQ · Traditional	Enthermics Medical Systems, Inc.	01/20/2000SE
K992258	Hot Shot Fluid Warmer IV FluidsLDQ · Traditional	Infra-Med Technologies, Inc.	01/12/2000SE
K981032	Piv SystemLDQ · Traditional	Medical Solutions, Inc.	09/02/1998SE
K955661	Acu-HaltLDQ · Traditional	Glederer & Co., Inc.	12/30/1996SE
K955776	Acu-LabLDQ · Traditional	Glederer & Co., Inc.	06/05/1996SE
K945374	Acu-HaltLDQ · Traditional	Eva-Health USA, Inc.	08/09/1995SE
K944961	Personal Alarm System (Pas)LDQ · Traditional	Cytoprobe Corp.	08/07/1995SE
K942810	Palco Labs Cold PouchLDQ · Traditional	Palco Laboratories, Inc.	06/28/1995SE
K930884	Medical Procedure Tray, ModificationLDQ · Traditional	Enpak Medical Corp.	03/21/1995SE
K934703	Medicool ProtectallLDQ · Traditional	Avc Regulatory Compliance/Technical Services	01/26/1994SE

More from Avc Regulatory Compliance/Technical Services

510(k)	Device	Decision
K973748	Tempo and Temp H20LGZ · Traditional	03/10/1998SE
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 Controlled Temperature Cabinet System cleared by the FDA?

Controlled Temperature Cabinet System (K973747) received a 510(k) decision of Substantially Equivalent on May 7, 1998, 218 days after the submission was received.