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510(k) K780458

TRANSCUTANEOUS OXYGEN PERFUSION MONITOR by Narco Air-Shields — Product Code KLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1978
Date Received
March 23, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device Class
Class II
Regulation Number
868.2500
Review Panel
AN
Submission Type

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  • K792117 — AIR-SHIELDS HEART RATE MONITOR (November 13, 1979)
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  • K790552 — AS7 & AS8 MONITORS (May 1, 1979)

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