2500 Printer

FDA 510(k) K860164 · Datascope Corp.

Substantially Equivalent

510(k) numberK860164

Submission

Device name
2500 Printer
Applicant
Datascope Corp.
Paramus, NJ, US
Received
January 17, 1986
Decision date
June 5, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

No product code recorded.

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Questions and answers

When was 2500 Printer cleared by the FDA?

2500 Printer (K860164) received a 510(k) decision of Substantially Equivalent on June 5, 1986, 139 days after the submission was received.