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510(k) K811424

ELECTRONIC APGAR TIMER by Pt&E — Product Code LHB

K811424 is an FDA 510(k) premarket notification submitted by Pt&E for the device "ELECTRONIC APGAR TIMER". The FDA issued a decision of Substantially Equivalent on July 9, 1981. The device falls under product code LHB (Timer, Apgar), a Class I device regulated under 21 CFR 880.2930.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 9, 1981
Date Received: May 22, 1981
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Timer, Apgar
Device Class: Class I
Regulation Number: 880.2930
Review Panel: HO
Submission Type