Heart - Aid Als, 95

FDA 510(k) K841556 · Cardiac Resucitator Corp.

Substantially Equivalent

510(k) numberK841556

Submission

Device name
Heart - Aid Als, 95
Applicant
Cardiac Resucitator Corp.
Mchenry, IL, US
Received
April 16, 1984
Decision date
July 19, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LDO – Enzymatic Radiochemical Assay, Tobramycin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3900
Specialty
Clinical Toxicology

Other 510(k)s with product code LDO

510(k)DeviceApplicantDecision
K043384Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers…LDO · Traditional Ortho-Clinical Diagnostics, Inc.02/07/2005SE
K832055Emit Assay and TobramycinLDO · Traditional Syva Co.08/08/1983SE

More from Syva Co.

510(k)DeviceDecision
K882513Modified Heart*Aid 97 Auto. External DefibrillatorDSI · Traditional 07/12/1988SE
K871971Modified Pace*Aid Model 53DRO · Traditional 06/24/1987SE
K871538Stat-Pad (TM)DRO · Traditional 06/24/1987SE
K871569Modified Heart*Aid 97 Auto. External DefibrillatorDRO · Traditional 06/08/1987SE
K870622Heart*Aid 1000MKJ · Traditional 04/10/1987SE
K850596Pace*Aid 10 a -Pad 10A- Pacemaker Output Display &DRO · Traditional 03/06/1985SE
K850170Heart Aid Model 97DRO · Traditional 02/14/1985SE
K844811Pace Aid Model 53DRO · Traditional 01/24/1985SE
K843547Pace *Aid Model 52DRO · Traditional 12/17/1984SE
K843358Heart-Aid Model 80DRO · Traditional 11/19/1984SE

Questions and answers

When was Heart - Aid Als, 95 cleared by the FDA?

Heart - Aid Als, 95 (K841556) received a 510(k) decision of Substantially Equivalent on July 19, 1984, 94 days after the submission was received.

What is the product code of K841556?

The FDA product code is LDO – Enzymatic Radiochemical Assay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.