OXIFLOW DIGITAL RECORDER— 510(k) K953363

Substantially Equivalent - Subject to Tracking Reg.

Edentec Corp.

FDA 510(k) clearance K953363 for OXIFLOW DIGITAL RECORDER, Substantially Equivalent - Subject to Tracking Reg. on 1996-02-06. Applicant: Edentec Corp..

Clearance details

Applicant: Edentec Corp.
Product code: Code BZQ
Advisory panel: Anesthesiology
Date received: 1995-07-17
Decision date: 1996-02-06
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: Eden Prairie, MN, US

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