FDA 510(k) Premarket Notification K042262: INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10

Submission Details & Decision

Normalized public record details for 510(k) notification K042262.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K042262

Applicant / Sponsor

Sequal Technologies, Inc.

Device Name

INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10

Product Code

CAW

Decision Date

2004-09-10

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Anesthesiology (AN)

Clearance Type

Special

Third Party Flag

Date Received

2004-08-23

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