510(k) K781413

MASK, PXYGEN by Vitalab Products Corp. — Product Code DPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1978
Date Received
August 15, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Blood-Flow, Extravascular
Device Class
Class II
Regulation Number
870.2120
Review Panel
CV
Submission Type