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510(k) K761215

F4912 NIGHT VISION AID by Itt Corp. — Product Code HPG

K761215 is an FDA 510(k) premarket notification submitted by Itt Corp. for the device "F4912 NIGHT VISION AID". The FDA issued a decision of Substantially Equivalent on December 16, 1976. The device falls under product code HPG (Aid, Vision, Electronic, Battery-Powered), a Class I device regulated under 21 CFR 886.5900.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 16, 1976
Date Received: December 7, 1976
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Aid, Vision, Electronic, Battery-Powered
Device Class: Class I
Regulation Number: 886.5900
Review Panel: OP
Submission Type