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510(k) K822301

ROYAL 1 OXYGEN CONCENTRATOR by Proto-Med, Inc. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1982
Date Received
August 3, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type

Other clearances by Proto-Med, Inc.

  • K844852 — THE GENERIC OXYGEN CONCENTRATOR (December 27, 1984)
  • K820115 — EMMETT IUD THREAD RETREIVER (February 5, 1982)
  • K811761 — THE EMMETT IUD THREAD RETRIEVER (September 21, 1981)

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