ESIS MODULE— 510(k) K780043

Substantially Equivalent

Datascope Corp.

FDA 510(k) clearance K780043 for ESIS MODULE, Substantially Equivalent on 1978-02-13. Applicant: Datascope Corp.. Device class: 2.

Clearance details

Applicant
Datascope Corp.
Product code
Code DRR
Device class
Class 2
Regulation
21 CFR 870.2050
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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