FDA 510(k) Application Details - K844328

Device Classification Name Generator, Oxygen, Portable

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510(K) Number K844328
Device Name Generator, Oxygen, Portable
Applicant HOSPITAK, INC.
1144 ROUTE 109
LINDENHURST, NY US
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Contact WILLIAM J LACEY
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Regulation Number 868.5440

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Classification Product Code CAW
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Date Received 11/07/1984
Decision Date 12/04/1984
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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