Home / 510(k) Clearances / K895274

510(k) K895274

HYPEX by Global Business, Inc. — Product Code BYW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1990
Date Received
August 23, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Rebreathing
Device Class
Class I
Regulation Number
868.5675
Review Panel
AN
Submission Type

Other clearances for product code BYW

  • K802165 — SHERWOOD VENTILATORY MUSCLE TRAINER (September 26, 1980)