FDA 510(k) Premarket Notification K942357: H-500 ALLIANCE OXYGEN CONCENTRATOR

Submission Details & Decision

Normalized public record details for 510(k) notification K942357.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K942357

Applicant / Sponsor

Healthdyne, Inc.

Device Name

H-500 ALLIANCE OXYGEN CONCENTRATOR

Product Code

CAW

Decision Date

1994-05-27

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Anesthesiology (AN)

Clearance Type

Traditional

Third Party Flag

Date Received

1994-05-17

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