Ionometer E-Hk and Accessories

FDA 510(k) K880373 · Smash Ent., Inc.

Substantially Equivalent

510(k) numberK880373

Submission

Device name
Ionometer E-Hk and Accessories
Applicant
Smash Ent., Inc.
Arden Hills, MN, US
Received
January 27, 1988
Decision date
March 17, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GKF – Instrument, Hematocrit, Automated
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5600
Specialty
Hematology

Other 510(k)s with product code GKF

510(k)DeviceApplicantDecision
K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin…GKF · Traditional Instrumentation Laboratory CO12/14/2016SE
K983551Crit-Scan II MonitorGKF · Traditional In-Line Diagnostics Corp.05/27/1999SE
K981427Stat Profile M AnalyzerGKF · Traditional Nova Biomedical Corp.05/12/1998SE
K981426Stat Profile Ultra F,G,H,I,J,K, and L AnalyzersGKF · Traditional Nova Biomedical Corp.05/12/1998SE
K981425Stat Profile Ultra a, B, C, D, and E AnalyzersGKF · Traditional Nova Biomedical Corp.05/12/1998SE
K953519Microspin 24GKF · Traditional Vulcon Technologies11/03/1995SE
K915825Marathon 6K General-Purpose CentrifugeGKF · Traditional Fisher Scientific Co., LLC03/11/1992SE
K915441Marathon 13K/H Microhematocrit CentrifugeGKF · Traditional Fisher Scientific Co., LLC01/08/1992SE
K904336New Cobe Saturation/Hematocrit MonitorGKF · Traditional Cobe Laboratories, Inc.12/27/1990SE
K870860Chempro 1000(TM)GKF · Traditional Arden Medical Systems, Inc.04/14/1987SE

More from Arden Medical Systems, Inc.

510(k)DeviceDecision
K880857Syringe Pump MS2000FRN · Traditional 09/01/1988SE
K881162Entera* Enteral Feeding BagKNT · Traditional 06/03/1988SE
K870183Ionometer Ef and AccessoriesJGS · Traditional 05/12/1987SE

Questions and answers

When was Ionometer E-Hk and Accessories cleared by the FDA?

Ionometer E-Hk and Accessories (K880373) received a 510(k) decision of Substantially Equivalent on March 17, 1988, 50 days after the submission was received.

What is the product code of K880373?

The FDA product code is GKF – Instrument, Hematocrit, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5600.