Accucom 2

FDA 510(k) K874138 · Datascope Corp.

Substantially Equivalent

510(k) numberK874138

Submission

Device name
Accucom 2
Applicant
Datascope Corp.
Paramus, NJ, US
Received
October 13, 1987
Decision date
June 1, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DPT – Probe, Blood-Flow, Extravascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2120
Specialty
Cardiovascular

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Questions and answers

When was Accucom 2 cleared by the FDA?

Accucom 2 (K874138) received a 510(k) decision of Substantially Equivalent on June 1, 1988, 232 days after the submission was received.

What is the product code of K874138?

The FDA product code is DPT – Probe, Blood-Flow, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2120.