Canmed 451

FDA 510(k) K905729 · Andover Medical, Inc.

Substantially Equivalent

510(k) numberK905729

Submission

Device name
Canmed 451
Applicant
Andover Medical, Inc.
Haverhill, MA, US
Received
December 24, 1990
Decision date
February 7, 1991
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 Canmed 451 cleared by the FDA?

Canmed 451 (K905729) received a 510(k) decision of Substantially Equivalent on February 7, 1991, 45 days after the submission was received.

What is the product code of K905729?

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