L30-LB- Infant Limb Band

FDA 510(k) K893245 · Contour Electrodes, Inc.

Substantially Equivalent

510(k) numberK893245

Submission

Device name
L30-LB- Infant Limb Band
Applicant
Contour Electrodes, Inc.
Herrin, IL, US
Received
April 28, 1989
Decision date
June 20, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DRX – Electrode, Electrocardiograph
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2360
Specialty
Cardiovascular

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Questions and answers

When was L30-LB- Infant Limb Band cleared by the FDA?

L30-LB- Infant Limb Band (K893245) received a 510(k) decision of Substantially Equivalent on June 20, 1989, 53 days after the submission was received.

What is the product code of K893245?

The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.