TEC 1410— 510(k) K904397

Substantially Equivalent

Bay Shore Medical Equipment Corp.

FDA 510(k) clearance K904397 for TEC 1410, Substantially Equivalent on 1990-11-13. Applicant: Bay Shore Medical Equipment Corp.. Device class: 1.

Clearance details

Applicant
Bay Shore Medical Equipment Corp.
Product code
Code IZO
Device class
Class 1
Regulation
21 CFR 892.1700
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bay Shore, NY, US
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